The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency and understand the regulatory framework. Will it work this time around? This blog article recaps how we got to this point...
Survival guide to stem cell research and therapiesArete-Zoe, LLC
Survival guide to stem cell research and therapies provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.
Potential: The first section explains how stem cells are currently used in research, drug testing, and therapy, and how they have to be manipulated before transfer to make any treatments possible.
Classification: Origin and ability of stem cells to differentiate into different cell types determine how different types of stem cells are typically used.
Clinical Research: In this section, we will introduce the two most important registries of clinical trials: NIH registry ClinicalTrials gov and WHO International Clinical Trials Registry Platform. A project is part of this section to give students the opportunity to get hands-on experience with collecting and collating relevant information from registries and libraries, and interpretation of the findings. Real-time interactive sessions are included to allow students to ask questions and offer additional guidance.
Patient Demand: In this section, we briefly introduce challenges relating to marketing claims, objective outcome measures, advertising strategies, and patient autonomy.
Regulatory and Legal Framework: Stem cell therapies are regulated differently in various countries around the world. In this section, we will focus on regulations that govern stem cell research and therapies in the U.S. and in the European Union. Policies on stem cell research are driven by ethical concerns relating to research that utilizes human embryos. China recently announced new ethical guidelines and new rules for its stem cell clinics, regulating both trials and treatments.
Professional Societies: The last section explains the role of professional societies in stem cell research and therapies.
Sunset Commission To Recommend Abolishing Anabolic Steroid Testing Programisteroidscom
According to a report released by the University Interscholastic League’s Anabolic Steroid Testing Program, no student-athlete at Texas public high schools tested positive for anabolic steroids during the 2013-14 school year.
Use of Genetic Databases to Advance Diagnostic Test DevelopmentEMMAIntl
In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for developers of genetic tests...
Whitley Smith has over 10 years of experience as a clinical laboratory scientist and supervisor. She holds a Bachelor of Science in Clinical Laboratory Sciences from Virginia Commonwealth University and is certified by the American Society of Clinical Pathology. Her work experience includes serving as Supervisor of Chemistry at West Anaheim Medical Center and working as a Medical Laboratory Scientist at Good Samaritan Regional Medical Center and Health Diagnostics Laboratory Inc. She has expertise in chemistry, hematology, urinalysis, coagulation, transfusion medicine, microbiology, and information technology systems for laboratories.
This document talks about the new rule that was suggested by U.S. Department of Health and Human Sciences (HHS), with respect to sharing of lab test results with patients, as an amendment to Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.
If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct biocompatibility testing. Biocompatibility testing is used to determine the “potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body”. The FDA relies heavily on ISO 10993 as the guiding force for biocompatibility testing in medical devices. This ISO standard is rooted in a risk-based approach to testing that the FDA views as the gold standard to ensure that medical devices do not cause adverse local or systemic effects due to contact with human tissue...
Pharmacists around the world are playing immense roles in the growth of Clinical Research. Some does contribute as a part of their profession and a few are passionate about their behind the scenes role.
Survival guide to stem cell research and therapiesArete-Zoe, LLC
Survival guide to stem cell research and therapies provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.
Potential: The first section explains how stem cells are currently used in research, drug testing, and therapy, and how they have to be manipulated before transfer to make any treatments possible.
Classification: Origin and ability of stem cells to differentiate into different cell types determine how different types of stem cells are typically used.
Clinical Research: In this section, we will introduce the two most important registries of clinical trials: NIH registry ClinicalTrials gov and WHO International Clinical Trials Registry Platform. A project is part of this section to give students the opportunity to get hands-on experience with collecting and collating relevant information from registries and libraries, and interpretation of the findings. Real-time interactive sessions are included to allow students to ask questions and offer additional guidance.
Patient Demand: In this section, we briefly introduce challenges relating to marketing claims, objective outcome measures, advertising strategies, and patient autonomy.
Regulatory and Legal Framework: Stem cell therapies are regulated differently in various countries around the world. In this section, we will focus on regulations that govern stem cell research and therapies in the U.S. and in the European Union. Policies on stem cell research are driven by ethical concerns relating to research that utilizes human embryos. China recently announced new ethical guidelines and new rules for its stem cell clinics, regulating both trials and treatments.
Professional Societies: The last section explains the role of professional societies in stem cell research and therapies.
Sunset Commission To Recommend Abolishing Anabolic Steroid Testing Programisteroidscom
According to a report released by the University Interscholastic League’s Anabolic Steroid Testing Program, no student-athlete at Texas public high schools tested positive for anabolic steroids during the 2013-14 school year.
Use of Genetic Databases to Advance Diagnostic Test DevelopmentEMMAIntl
In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for developers of genetic tests...
Whitley Smith has over 10 years of experience as a clinical laboratory scientist and supervisor. She holds a Bachelor of Science in Clinical Laboratory Sciences from Virginia Commonwealth University and is certified by the American Society of Clinical Pathology. Her work experience includes serving as Supervisor of Chemistry at West Anaheim Medical Center and working as a Medical Laboratory Scientist at Good Samaritan Regional Medical Center and Health Diagnostics Laboratory Inc. She has expertise in chemistry, hematology, urinalysis, coagulation, transfusion medicine, microbiology, and information technology systems for laboratories.
This document talks about the new rule that was suggested by U.S. Department of Health and Human Sciences (HHS), with respect to sharing of lab test results with patients, as an amendment to Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.
If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct biocompatibility testing. Biocompatibility testing is used to determine the “potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body”. The FDA relies heavily on ISO 10993 as the guiding force for biocompatibility testing in medical devices. This ISO standard is rooted in a risk-based approach to testing that the FDA views as the gold standard to ensure that medical devices do not cause adverse local or systemic effects due to contact with human tissue...
Pharmacists around the world are playing immense roles in the growth of Clinical Research. Some does contribute as a part of their profession and a few are passionate about their behind the scenes role.
An EHR/HIE system in Jackson, Michigan connects about 50% of the local providers including hospitals, private practices, FQHCs, and health departments since 2005. It allows for shared patient records including medications, allergies, notes, orders, and results across all connected practices to improve care coordination and reduce duplicative tests. The system serves over 140,000 patients and processes hundreds of thousands of lab, radiology, and hospital reports each month.
This document discusses the potential for plant-based toxicity screening as an alternative to animal testing in drug development. It summarizes that:
1) Current animal testing for drug safety is costly, time-consuming, and raises ethical issues, while cell culture methods are unreliable.
2) The company, 3R Laboratories, aims to improve drug safety and reduce animal experiments through predictive toxicology using plant models.
3) Their plant respiration test could provide a reproducible, sensitive way to rank compounds by toxicity and help pharmaceutical companies avoid costly drug failures in clinical trials.
Off-label drug use refers to when a drug is used in a way that is different from its FDA-approved label, such as being given in a different dose or route, or used to treat a different disease. While doctors can legally prescribe drugs off-label, drug companies cannot market drugs for off-label uses. Off-label drug use is common in cancer treatment because some cancer drugs work against many tumor types and cancer treatment is constantly evolving. When considering off-label drug treatment, patients should ask about the evidence and risks/benefits compared to approved drugs. The FDA could better regulate off-label use by systematically collecting post-market data on harms and benefits and disseminating reports on off-label evidence
The document is a certificate from the American Psychiatric Association certifying that Paula Alina Dima completed an online clinical vignette self-assessment activity titled "Doc I Always Hurt, An APA eFocus Clinical Vignette Self-Assessment: Understanding the Evidence (With Authorization Code)" on March 9, 2015. The APA awards 2.00 AMA PRA Category 1 credits for completion of the activity. The certificate includes Paula Dima's name, the activity name and date, and the number of credits awarded.
The Skeeterhawk Experiment 2013 Slide Presentation (Prescription Drug Misuse)Skeeterhawk
The Skeeterhawk Experiment was organized in March 2013 to help end the scourge of prescription drug misuse through the testing of innovative prevention, treatment, and overdose rescue strategies in real-life communities, beginning in Northeast Florida. Utilizing data gathered from a multitude of reliable sources, The Skeeterhawk Experiment believes it is possible for every community to devise targeted, data-driven strategies to tackle its unique set of prescription drug misuse problems. This is the organization's Northeast Florida community presentation for 2013.
The document describes an online resource from the March of Dimes called Genetics & Your Practice that provides professionals information and tools to integrate genetics into daily practice. It offers guidelines on genetic testing, family history, and referrals as well as step-by-step algorithms. Users can download forms, questionnaires, and information for patients. The site also provides free continuing medical education credits through interactive case studies on topics like cystic fibrosis and cancer.
Damaris Mejia provides her contact information and educational background which includes a post-baccalaureate degree in cellular/molecular/physiology/microbiology from California State University, Northridge and a bachelor's degree in biology also from California State University, Northridge. She has extensive experience in cancer research, cellular/molecular/physiology research, medical microbiology/immunology, cell and plant tissue culture, and clinical practices including medical administration and quality control. Her skills include proficiency with Microsoft Office, statistical analysis, and oral and written communication.
Visual Analytic Approaches for the Analysis of Spontaneously Reported Adverse...JMP software from SAS
This document discusses approaches for analyzing spontaneously reported adverse events from post-market drug surveillance. It describes how clinical trials provide an incomplete safety profile and how data from post-market use can reveal rare or long-term safety issues. Statistical methods like disproportionality analysis are used to detect unexpected drug-event combinations in spontaneous reporting data by comparing the frequency of reports for a drug-event pair to what would be expected based on overall reporting rates. Stratifying the data by patient characteristics can improve the accuracy of these analyses. Signals of disproportionate reporting are defined as drug-event pairs where the confidence or credible interval for their association exceeds a threshold value.
1) Using data from Utah's Controlled Substance Database from 2006-2007, the researchers created a 9-digit mixed identifier field by extracting and validating 9-digit IDs from the customer ID field to enhance record linkage.
2) Linkage using the 9-digit mixed ID field resulted in approximately 20% more matched pairs found with the highest certainty compared to linkage without the mixed ID field. It also resulted in approximately 14% more matches using both deterministic and probabilistic linkage methods.
3) The researchers concluded that creating a mixed ID field by extracting 9-digit IDs from a customer ID field containing various data types improves the quality of record linkage results.
Sputnik, su The Lancet la lettera che contesta i dati della sperimentazioneilfattoquotidiano.it
The authors raise several concerns with the interim phase 3 trial data reported for the Sputnik V COVID-19 vaccine. They found inconsistencies in the reported data, including discrepancies in the numbers of participants between tables and figures. Additionally, the authors question the highly coincidental efficacy results reported across age groups and find issues with lack of access to the full trial protocol and raw data. They invite investigators to make the full data publicly available for independent scrutiny.
The document lists and describes various drug information resources available at hospitals and through library subscriptions, including Micromedex, Facts & Comparisons, MDConsult, AccessMedicine, DynaMed, StatRef, Goodman & Gilman’s Basic & Clinical Pharmacology, Poisoning and Drug Overdose, and AHFS DI Essentials. It also outlines free internet resources such as the NLM Drug Portal, RxList, Drugs.com, Epocrates Online, and the Johns Hopkins Antibiotic Guide. PDA resources mentioned include Epocrates, MicroMedex/Thomson Clinical Xpert, Tarascon, and Lexi-Drugs.
Microneedle technology is attaining commercial viability at a time when drug developers are faced with new challenges as they assess ways to administer new classes of compounds with significant therapeutic potential. The widespread availability of rapid throughput screening is accelerating the discovery of new drugs, a significant number of which are large-molecule therapeutic compounds that cannot tolerate passage through the digestive system, requiring pharmaceutical companies to forego oral formulations and select alternate routes of administration.Highlights' Provides assessments of microneedles drug delivery devices, patches, syringes and systems' Analyzes and evaluates microneedle technology and assesses the medical market potential for existing and probable future products' Provides detailed descriptions of microneedle system business opportunities, market demographics, and business strategies' Provides market data and forecasts to 2016' Profiles microneedle drug delivery product and technology participants, their activities, business strategies, and corporate alliances and affiliations
Business Systems for Pharmaceutical IndustryDella Fong
This document discusses how information systems can help with various aspects of pharmaceutical research, development, and medical business. It outlines the roles of information systems in discovery research, clinical development, safety, medical, and regulatory areas. Specifically, it mentions systems that can help with areas like comparative medicine, chemistry, pharmacology, clinical trials, supply chain management, safety reporting, and regulatory submissions. The overall message is that information systems can provide assistance across the entire pharmaceutical development process from early research to final medicine.
Bedside barcoding is a new medical advancement that uses barcodes on patient bracelets matched with barcoded medications to positively identify patients and ensure the right patient receives the right medication dose at the right time. Nurses scan their badge, the patient's bracelet, and the packaged medication barcode before administration to verify this information. While this process is time consuming and requires training, it provides accurate documentation of medications administered and reduces medical errors by preventing confusion between similarly named drugs.
The FDA has released an action plan to encourage more diverse participation in clinical trials and increase reporting of patient demographic data such as age, race, and gender. The plan follows a 2013 report to Congress on these issues. The FDA also announced a pilot program to qualify regulatory tools for medical device development to improve efficiency and allow earlier access to novel technologies for U.S. patients. Up to 15 proposals for tools such as clinical assessments, biomarkers, and computer models will be selected for the program.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Direct-to-consumer personal genome testing allows customers to order genetic testing kits online, swab their cheek for a DNA sample, send it to a lab for analysis, and access their results online. While this provides information about disease risks and ancestry, there are also ethical concerns like inaccurate results, lack of counseling, and potential for genetic discrimination. Regulators in the US face challenges overseeing these tests, as some laboratories develop their own tests which escape FDA review, and tests may be used for purposes other than their intended use. The solution may lie in expanding post-market surveillance and regulation as is done for drug approval.
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
An EHR/HIE system in Jackson, Michigan connects about 50% of the local providers including hospitals, private practices, FQHCs, and health departments since 2005. It allows for shared patient records including medications, allergies, notes, orders, and results across all connected practices to improve care coordination and reduce duplicative tests. The system serves over 140,000 patients and processes hundreds of thousands of lab, radiology, and hospital reports each month.
This document discusses the potential for plant-based toxicity screening as an alternative to animal testing in drug development. It summarizes that:
1) Current animal testing for drug safety is costly, time-consuming, and raises ethical issues, while cell culture methods are unreliable.
2) The company, 3R Laboratories, aims to improve drug safety and reduce animal experiments through predictive toxicology using plant models.
3) Their plant respiration test could provide a reproducible, sensitive way to rank compounds by toxicity and help pharmaceutical companies avoid costly drug failures in clinical trials.
Off-label drug use refers to when a drug is used in a way that is different from its FDA-approved label, such as being given in a different dose or route, or used to treat a different disease. While doctors can legally prescribe drugs off-label, drug companies cannot market drugs for off-label uses. Off-label drug use is common in cancer treatment because some cancer drugs work against many tumor types and cancer treatment is constantly evolving. When considering off-label drug treatment, patients should ask about the evidence and risks/benefits compared to approved drugs. The FDA could better regulate off-label use by systematically collecting post-market data on harms and benefits and disseminating reports on off-label evidence
The document is a certificate from the American Psychiatric Association certifying that Paula Alina Dima completed an online clinical vignette self-assessment activity titled "Doc I Always Hurt, An APA eFocus Clinical Vignette Self-Assessment: Understanding the Evidence (With Authorization Code)" on March 9, 2015. The APA awards 2.00 AMA PRA Category 1 credits for completion of the activity. The certificate includes Paula Dima's name, the activity name and date, and the number of credits awarded.
The Skeeterhawk Experiment 2013 Slide Presentation (Prescription Drug Misuse)Skeeterhawk
The Skeeterhawk Experiment was organized in March 2013 to help end the scourge of prescription drug misuse through the testing of innovative prevention, treatment, and overdose rescue strategies in real-life communities, beginning in Northeast Florida. Utilizing data gathered from a multitude of reliable sources, The Skeeterhawk Experiment believes it is possible for every community to devise targeted, data-driven strategies to tackle its unique set of prescription drug misuse problems. This is the organization's Northeast Florida community presentation for 2013.
The document describes an online resource from the March of Dimes called Genetics & Your Practice that provides professionals information and tools to integrate genetics into daily practice. It offers guidelines on genetic testing, family history, and referrals as well as step-by-step algorithms. Users can download forms, questionnaires, and information for patients. The site also provides free continuing medical education credits through interactive case studies on topics like cystic fibrosis and cancer.
Damaris Mejia provides her contact information and educational background which includes a post-baccalaureate degree in cellular/molecular/physiology/microbiology from California State University, Northridge and a bachelor's degree in biology also from California State University, Northridge. She has extensive experience in cancer research, cellular/molecular/physiology research, medical microbiology/immunology, cell and plant tissue culture, and clinical practices including medical administration and quality control. Her skills include proficiency with Microsoft Office, statistical analysis, and oral and written communication.
Visual Analytic Approaches for the Analysis of Spontaneously Reported Adverse...JMP software from SAS
This document discusses approaches for analyzing spontaneously reported adverse events from post-market drug surveillance. It describes how clinical trials provide an incomplete safety profile and how data from post-market use can reveal rare or long-term safety issues. Statistical methods like disproportionality analysis are used to detect unexpected drug-event combinations in spontaneous reporting data by comparing the frequency of reports for a drug-event pair to what would be expected based on overall reporting rates. Stratifying the data by patient characteristics can improve the accuracy of these analyses. Signals of disproportionate reporting are defined as drug-event pairs where the confidence or credible interval for their association exceeds a threshold value.
1) Using data from Utah's Controlled Substance Database from 2006-2007, the researchers created a 9-digit mixed identifier field by extracting and validating 9-digit IDs from the customer ID field to enhance record linkage.
2) Linkage using the 9-digit mixed ID field resulted in approximately 20% more matched pairs found with the highest certainty compared to linkage without the mixed ID field. It also resulted in approximately 14% more matches using both deterministic and probabilistic linkage methods.
3) The researchers concluded that creating a mixed ID field by extracting 9-digit IDs from a customer ID field containing various data types improves the quality of record linkage results.
Sputnik, su The Lancet la lettera che contesta i dati della sperimentazioneilfattoquotidiano.it
The authors raise several concerns with the interim phase 3 trial data reported for the Sputnik V COVID-19 vaccine. They found inconsistencies in the reported data, including discrepancies in the numbers of participants between tables and figures. Additionally, the authors question the highly coincidental efficacy results reported across age groups and find issues with lack of access to the full trial protocol and raw data. They invite investigators to make the full data publicly available for independent scrutiny.
The document lists and describes various drug information resources available at hospitals and through library subscriptions, including Micromedex, Facts & Comparisons, MDConsult, AccessMedicine, DynaMed, StatRef, Goodman & Gilman’s Basic & Clinical Pharmacology, Poisoning and Drug Overdose, and AHFS DI Essentials. It also outlines free internet resources such as the NLM Drug Portal, RxList, Drugs.com, Epocrates Online, and the Johns Hopkins Antibiotic Guide. PDA resources mentioned include Epocrates, MicroMedex/Thomson Clinical Xpert, Tarascon, and Lexi-Drugs.
Microneedle technology is attaining commercial viability at a time when drug developers are faced with new challenges as they assess ways to administer new classes of compounds with significant therapeutic potential. The widespread availability of rapid throughput screening is accelerating the discovery of new drugs, a significant number of which are large-molecule therapeutic compounds that cannot tolerate passage through the digestive system, requiring pharmaceutical companies to forego oral formulations and select alternate routes of administration.Highlights' Provides assessments of microneedles drug delivery devices, patches, syringes and systems' Analyzes and evaluates microneedle technology and assesses the medical market potential for existing and probable future products' Provides detailed descriptions of microneedle system business opportunities, market demographics, and business strategies' Provides market data and forecasts to 2016' Profiles microneedle drug delivery product and technology participants, their activities, business strategies, and corporate alliances and affiliations
Business Systems for Pharmaceutical IndustryDella Fong
This document discusses how information systems can help with various aspects of pharmaceutical research, development, and medical business. It outlines the roles of information systems in discovery research, clinical development, safety, medical, and regulatory areas. Specifically, it mentions systems that can help with areas like comparative medicine, chemistry, pharmacology, clinical trials, supply chain management, safety reporting, and regulatory submissions. The overall message is that information systems can provide assistance across the entire pharmaceutical development process from early research to final medicine.
Bedside barcoding is a new medical advancement that uses barcodes on patient bracelets matched with barcoded medications to positively identify patients and ensure the right patient receives the right medication dose at the right time. Nurses scan their badge, the patient's bracelet, and the packaged medication barcode before administration to verify this information. While this process is time consuming and requires training, it provides accurate documentation of medications administered and reduces medical errors by preventing confusion between similarly named drugs.
The FDA has released an action plan to encourage more diverse participation in clinical trials and increase reporting of patient demographic data such as age, race, and gender. The plan follows a 2013 report to Congress on these issues. The FDA also announced a pilot program to qualify regulatory tools for medical device development to improve efficiency and allow earlier access to novel technologies for U.S. patients. Up to 15 proposals for tools such as clinical assessments, biomarkers, and computer models will be selected for the program.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Direct-to-consumer personal genome testing allows customers to order genetic testing kits online, swab their cheek for a DNA sample, send it to a lab for analysis, and access their results online. While this provides information about disease risks and ancestry, there are also ethical concerns like inaccurate results, lack of counseling, and potential for genetic discrimination. Regulators in the US face challenges overseeing these tests, as some laboratories develop their own tests which escape FDA review, and tests may be used for purposes other than their intended use. The solution may lie in expanding post-market surveillance and regulation as is done for drug approval.
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
This editorial discusses regulatory issues with medical devices. It notes recalls of breast implants and hip implants that reflect failings in regulation. Medical device regulation in Europe and the US is described as having low evidentiary standards, often only requiring devices to be "substantially equivalent" to existing ones without clinical trials. This has led to unsafe devices being approved and problems going unnoticed. Stricter evidence requirements are needed prior to approval, especially for implantable devices, to better protect patients.
Using real-time-data-to-drive-better-decisions-fasterPrateek Rathi
This document discusses the opportunities and risks associated with using real-time data access during clinical trials. It examines how real-time data can enhance patient safety, strengthen quality, and accelerate timelines by allowing drug developers to review data shortly after collection and make faster decisions. However, it also notes risks like unintentionally unblinding trials or introducing bias if not properly controlled. The document provides guidelines for granting access based on roles and recommends only giving access to pre-treatment data rather than on-treatment data to most roles. It emphasizes the need for protocols outlining how real-time data will be used and establishing firewalls to mitigate risks while enabling the benefits of real-time data reviews.
FDA classify Medical Devices and how to report device problems A Systematic R...Pubrica
The typical time it takes to get a device to market is 3 to 7 years, compared to 12 years for pharmaceuticals. However, there are concerns that the Food and Drug Administration's Systematic Review Writing methods may not be adequate to satisfy the required guarantees of safety and efficacy.
Learn More : https://pubrica.com/services/research-services/systematic-review/
Reference: https://bit.ly/3xNHUsC
Why Pubrica:
When you order our services, we promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Bio statistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
The FDA is seeking input on modernizing its regulations and practices for clinical trials to address increased complexity and globalization of trials. It is asking how it can encourage innovative methods to build quality into trials and eliminate challenges posed by its regulations. A public hearing was held in April where several industry speakers presented, including the CEO recommending regulatory harmonization and relief from IND safety letters. Comments can be submitted to the FDA until May 31. The newsletter then discusses two research topics - a FDA guidance on IRB continuing review criteria, emphasizing the sponsor's role in providing study-wide information, and state laws regarding consent for research with pregnant minors.
Quorum Review's July 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing support for effective human research protection programs, as well as Quorum's insights on two important topics: The first addresses exculpatory language in consent forms; the second provides insight on considerations when planning eConsent implementation and questions to ask the IRB.
Drazen transparency for clinical trials -- the test actMarilyn Mann
The TEST Act aims to close loopholes in clinical trial registration and results reporting. It would require registration and results reporting for all interventional studies, regardless of phase, design, or approval status. This would provide a more complete public record of clinical trials and their results. The Act also mandates registration and reporting of foreign trials used to support FDA applications. Overall, the TEST Act furthers the goal of conducting clinical research transparently and ensuring trial participants see the benefits of their contributions.
The document discusses informed consent regulations for research using leftover human biospecimens. It argues that moving to a broad consent standard could undermine public trust by prioritizing medical discovery over patient rights and privacy. Broad consent forms may confuse patients and fail to prevent unforeseen future uses of their genetic data. The regulations do not sufficiently prevent re-identification of specimens. Amendments are needed to clarify allowed re-identification circumstances and require prior written authorization. Separating informed consent for treatment from broad consent for unspecified future research allows patients to proceed with procedures without implied consent to downstream uses of their specimens.
The document summarizes FDA's drug review process. Key points:
1. FDA's Center for Drug Evaluation and Research (CDER) ensures drugs marketed in the US are safe and effective. CDER reviews new drug applications but does not test drugs itself.
2. Developing a new drug involves preclinical testing, clinical trials in 3 phases with increasing number of participants, and submitting a New Drug Application for FDA review.
3. The FDA review process evaluates whether clinical trials demonstrate a drug's safety and effectiveness for its intended use. If approved, the FDA continues monitoring the drug for safety after market.
FDA classify Medical Devices and how to report device problems A Systematic R...Pubrica
The typical time it takes to get a device to market is 3 to 7 years, compared to 12 years for pharmaceuticals. However, there are concerns that the Food and Drug Administration's Systematic Review Writing methods may not be adequate to satisfy the required guarantees of safety and efficacy.
Learn More : https://pubrica.com/services/research-services/systematic-review/
Reference: https://bit.ly/3xNHUsC
Why Pubrica:
When you order our services, we promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Bio statistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
An overview of the current regulatory environment. *This is not legal advice and is written by a non-attorney. This is general information from a student in law school (MSJ program).
This white paper discusses four ways that pharmaceutical and biotechnology companies can accelerate their clinical portfolio strategy using advanced analytics and clinical trial data and technology. It provides examples of how visualizing clinical trial data over time, benchmarking trial durations, mapping competitive drug pipelines, and comparing safety profiles across trials can provide insights to help with strategic decision making regarding clinical development.
Neglected and rare diseases traditionally have not been the focus of large pharmaceutical company research as biotech and academia have primarily been involved in drug discovery efforts for such diseases. This area certainly represents a new opportunity as the pharmaceutical industry investigates new markets. One approach to speed up drug discovery is to examine new uses for existing approved drugs; this is termed drug repositioning or drug repurposing and has become increasingly popular in recent years. Analysis of the literature reveals that using high-throughput screening there have been many examples of FDA approved drugs found to be active against additional targets that can be used to therapeutic advantage for repositioning for other diseases. To date there are far fewer such examples where in silico approaches have allowed for the derivation of new uses. It is suggested that with current technologies and databases of chemical compounds (drugs) and related data, as well as close integration with in vitro screening data, improved opportunities for drug repurposing will emerge. In this publication a review of the literature will highlight several proof of principle examples from areas such as finding new inhibitors for drug transporters with 3D pharmacophores and uncovering molecules active against Mycobacterium tuberculosis (Mtb) using Bayesian models of compound libraries. Research into neglected or rare/orphan diseases can likely benefit from in silico drug repositioning approaches and accelerate drug discovery for these diseases.
This document discusses the FDA's perspective on regulating cellular therapies. It provides the following key points:
1. The FDA regulates cellular therapies as drugs, biological products, and human cells/tissues under various regulations including cGMP, biological product regulations, labeling regulations, and HCT/P regulations.
2. Cellular therapies present challenges for development and regulation due to their complex nature involving living cells.
3. The document provides tips for navigating FDA regulations during development, including being data-driven, providing complete documentation, being informed of FDA resources, communicating with the FDA, and planning ahead.
The document discusses the increasing need for companion diagnostics to accompany targeted cancer therapies. It outlines three categories of diagnostic development: 1) Co-development of the drug and diagnostic from an early stage; 2) Development of a diagnostic after a drug is approved to identify patients who will benefit; and 3) Development of a diagnostic for one indication that is later repurposed for another. It also discusses the regulatory environment, noting that regulatory agencies like the FDA are increasingly requiring companion diagnostics and biomarkers to guide patient selection and drug approval. Developing diagnostics poses challenges for drug companies who must partner with diagnostic firms and navigate regulatory requirements.
What's In An Idea-Chanda-UofT Life Science CoachDebra A. Chanda
The document discusses challenges and opportunities in the medical innovation process. It notes that while regulatory approval and reimbursement processes can be slow, improvements are being made. Medical device innovation requires collaboration between physicians, engineers, and industry. The future includes more implanted diagnostics to better manage diseases and promote wellness. Overall, the field remains promising for new technologies despite barriers that can be further addressed.
Special Challenges in Clinical Trials: Case Study: the Dying child and the ...Michael Swit
A review of a case study involving whether it would be proper to authorize the use of a drug whose approval had been withdrawn when it is believed to be the only hope for a dying child.
Two cartilage regeneration techniques are briefly covered: Autologous Chondrocyte Implantation (ACI) and Autologous Matrix-Induced Chondrogenesis (AMIC). ACI involves taking cartilage cells from a non-load bearing area, multiplying them in a lab, and re-injecting them into damaged cartilage in two surgeries. AMIC requires only one surgery - the damaged cartilage is removed, the area is stimulated with microfractures, and a collagen membrane placed over the site promotes new cartilage growth from stem cells. These techniques and bio-scaffold technologies offer potential long-term solutions for cartilage conditions and regeneration of original cartilage properties.
Stability Testing of Pharmaceuticals and SupplementsEMMAIntl
Whether you are working on a prescription drug, over-the-counter (OTC) drug, or even a dietary supplement, stability testing is required depending on the location of registration and agencies involved in its approval. Stability testing is the method of testing a product's safety, efficacy, and chemical composition after a set period...
Millions in the United States alone have an allergic condition, with many of these allergies being related to food. According to the Food Allergy Research & Education organization (FARE) 32 million Americans have food allergies. Of those 32 million, 200,000 require emergency medical care for allergic reactions from those foods. A common misconception is that food intolerance is a food allergy when in actuality that is its own unique category...
The field of biomedical engineering is a new, widely researched, and well-funded industry that aims to tackle problems in medicine and health by providing engineered solutions. These solutions might be delivered in the form of electrical hardware, chemicals, or even software. Given the extensive range of applications that exist in the medical device industry, the field is continuously accelerating its innovations in technology via an abundance of research and innovation outlets in countless interrelated fields. One of the many fields that are fundamentally fueling the growth of the biomedical industry is material science...
Investigating Ketamine for Parkinson’s DiseaseEMMAIntl
In May 2021, the FDA approved an Investigational New Drug (IND) application from PharmaTher Holdings Ltd., to proceed with a Phase Two clinical trial. PharmaTher Holdings Ltd. is a psychedelics biotech organization that focuses on research and development, and commercialization of psychedelics to treat pain and neurological disorders, and mental illnesses. This company is headquartered in Vancouver, Canada...
Aduhelm, an Accelerated Approval for Alzheimer’sEMMAIntl
Alzheimer’s disease is the most common cause of dementia, especially in patients aged 65 and older1. Alzheimer’s disease is a neurodegenerative disease that has a direct correlation to age: as age increases, the likelihood of developing Alzheimer’s increases as well. Alzheimer’s has long been a subject of discussion in the pharmaceutical industries and, until the FDA’s recent accelerated approval of Aduhelm earlier this month, the most recent treatment approved for Alzheimer’s was in 2003, almost two decades ago. The FDA’s approval of Aduhelm represents the first-of-its-kind treatment and is the first therapy that aims to interrupt the underlying physiological pathway of Alzheimer’s, rather than simply attempt to treat its symptoms...
Every June 14th, the World Health Organization (WHO) hosts World Blood Donor Day to raise awareness all over the globe for how crucial the need for safe blood is in the healthcare industry. In the US and Canada alone, 43,000 pints of blood are used each day for life-saving procedures and treatments...
Starting in Summer 2021, a new type of COVID vaccine could be available. Known as a protein subunit vaccine, this vaccine contains a spike protein that the other three vaccines are missing. The other vaccines, Pfizer, Moderna, and Johnson & Johnson, contain instructions for the spike protein but do not actually include the spike protein in the vaccination. The three vaccines allow our cell bodies to make the protein up for itself...
June 14th through the 20th is Men’s Health Week, which is a great opportunity to heighten awareness for men’s depression. There is a theme in society applicable to most men as they tend to internalize depressive thoughts, not allowing for a proper diagnosis. There are four major reasons men do not reach out for help with their depression: failure to recognize the depression consuming them, downplaying signs and symptoms, reluctance to converse about their feelings with others, and resisting mental health treatment...
Celebrating Pride Month at EMMA InternationalEMMAIntl
June 1 started the celebration of Pride Month, which commemorates Lesbian, Gay, Bisexual, and Transgender members. Celebrating Pride Month is also more than celebrating members of the LGBTQIA+, this month is also about recognizing that diversity fuels innovation and collaboration among a variety of industries, including the life sciences...
Growth and Integration of ML/AI in BiotechEMMAIntl
The biotechnology and pharmaceutical industries are heavily reliant on collecting, storing, and analyzing data for both R&D as well as production purposes. The large, countless, and rapidly growing sets of data are critical for researchers and scientists to accelerate progress in the medical industry. As our technologies advance and our capacity to store data continue to increase, we must continue to find new ways to efficiently analyze data. Researchers at the European Bioinformatics Institute (EMBL-EBI) have determined that nucleotide and proteomics data is growing at an exponential rate, with the amount of data stored on their servers doubling each year...
Quality Function Deployment, or QFD, is a decades-old methodology focused on the voice of the customer. It was initially developed in Japan in the 1960s but was popularized in the US by the automotive industry in the 1980s . QFD is a tool often leveraged by Total Quality Management (TQM), which is a quality principle that customers define quality and subsequently should be prioritized at all stages of the product, both pre-and post-production...
New digital health technology is coming out every day and is changing the course of the MedTech industry as we know it. Many physicians are making the transition to using these digital health devices and technologies to improve patient care and outcomes. Some of this increase can be attributed to COVID-19 of course as it enabled them to provide care for patients remotely. However, many of these digital health devices and technologies have been around for a bit, so what caused the hesitation in adapting them sooner and what are some of the great perks of this new wave of medical care?
Immune Systems After the COVID-19 PandemicEMMAIntl
Everyone has heard that immune systems weaken when they are sheltered, but is that really the case? As we are now over one year into lockdowns and social distancing, many are becoming concerned that after the pandemic immune systems are going to falter after being isolated for such a long period, and many adults are concerned to resume a “normal” life due to this...
Stability Testing Requirements for PharmaceuticalsEMMAIntl
Deciding how and when to conduct stability tests on your new drug can be challenging. Stability tests provide evidence data on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors. It also establishes a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions...
EMMA International is continuing to celebrate Women’s Health Week! While there are so many reasons Women’s Health Week is important, one of the best things to come out of this week is the attention it brings and the reminders that we should all consider our health and take steps to ensure a healthy future...
Happy National Women’s Health Week! In honor of this week bringing light to important women’s health issues, I wanted to walk through a brief history of innovations that shaped one of the largest facets of women’s health – reproductive health...
Electronic signatures have become increasingly important with the shift to remote work during the pandemic. 21CFR§11 provides regulations for electronic signatures and documentation in FDA-regulated industries to ensure validation and compliance. The regulations require that each electronic signature be unique to an individual and that their identity is authenticated, often with a password or pin. Software used must also maintain traceability of electronic signatures. While there are pre-validated software options, manufacturers are responsible for additionally validating software for their intended use and 21CFR§11 compliance. EMMA International offers assistance with software validation to support compliance with regulatory requirements.
Considerations for Biocompatibility EvaluationEMMAIntl
Biocompatibility is one of the most critical performance studies that manufacturers need to perform as part of their product development process. ISO 10993-5 and ISO 10993-10 are FDA-recognized standards for biocompatibility. Whether you perform these studies in-house or send out samples to a third-party lab the protocol for biocompatibility assessment must be conducted in accordance with ISO 10993...
Restoring the Earth for a Healthier FutureEMMAIntl
Today marks the 52nd anniversary of the birth of the true modern environmental movement, however, you probably know it as Earth Day. Early in the pandemic, many hoped that the lockdowns would help the Earth heal as people began to stay home, stopped commuting, and some factories even had paused production. Unfortunately, as things are beginning to open back up emissions are on the rise again and we need to continue to think about the future consequences...
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdfDr Rachana Gujar
The "Comprehensive Rainy Season Advisory: Safety and Preparedness Tips" offers essential guidance for navigating rainy weather conditions. It covers strategies for staying safe during storms, flood prevention measures, and advice on preparing for inclement weather. This advisory aims to ensure individuals are equipped with the knowledge and resources to handle the challenges of the rainy season effectively, emphasizing safety, preparedness, and resilience.
Joker Wigs has been a one-stop-shop for hair products for over 26 years. We provide high-quality hair wigs, hair extensions, hair toppers, hair patch, and more for both men and women.
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)bkling
Your mindset is the way you make sense of the world around you. This lens influences the way you think, the way you feel, and how you might behave in certain situations. Let's talk about mindset myths that can get us into trouble and ways to cultivate a mindset to support your cancer survivorship in authentic ways. Let’s Talk About It!
Healthy Eating Habits:
Understanding Nutrition Labels: Teaches how to read and interpret food labels, focusing on serving sizes, calorie intake, and nutrients to limit or include.
Tips for Healthy Eating: Offers practical advice such as incorporating a variety of foods, practicing moderation, staying hydrated, and eating mindfully.
Benefits of Regular Exercise:
Physical Benefits: Discusses how exercise aids in weight management, muscle and bone health, cardiovascular health, and flexibility.
Mental Benefits: Explains the psychological advantages, including stress reduction, improved mood, and better sleep.
Tips for Staying Active:
Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
Maintaining a Balanced Lifestyle:
Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
The facial nerve, also known as cranial nerve VII, is one of the 12 cranial nerves originating from the brain. It's a mixed nerve, meaning it contains both sensory and motor fibres, and it plays a crucial role in controlling various facial muscles, as well as conveying sensory information from the taste buds on the anterior two-thirds of the tongue.
LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
This webinar helps clinicians understand the unique healthcare needs of the LGBTQ+ community, primarily in relation to end-of-life care. Topics include social and cultural background and challenges, healthcare disparities, advanced care planning, and strategies for reaching the community and improving quality of care.
At Apollo Hospital, Lucknow, U.P., we provide specialized care for children experiencing dehydration and other symptoms. We also offer NICU & PICU Ambulance Facility Services. Consult our expert today for the best pediatric emergency care.
For More Details:
Map: https://cutt.ly/BwCeflYo
Name: Apollo Hospital
Address: Singar Nagar, LDA Colony, Lucknow, Uttar Pradesh 226012
Phone: 08429021957
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Michigan HealthTech Market Map 2024. Includes 7 categories: Policy Makers, Academic Innovation Centers, Digital Health Providers, Healthcare Providers, Payers / Insurance, Device Companies, Life Science Companies, Innovation Accelerators. Developed by the Michigan-Israel Business Accelerator
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardso...rightmanforbloodline
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
Letter to MREC - application to conduct studyAzreen Aj
Application to conduct study on research title 'Awareness and knowledge of oral cancer and precancer among dental outpatient in Klinik Pergigian Merlimau, Melaka'
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
Exploring the Benefits of Binaural Hearing: Why Two Hearing Aids Are Better T...Ear Solutions (ESPL)
Binaural hearing using two hearing aids instead of one offers numerous advantages, including improved sound localization, enhanced sound quality, better speech understanding in noise, reduced listening effort, and greater overall satisfaction. By leveraging the brain’s natural ability to process sound from both ears, binaural hearing aids provide a more balanced, clear, and comfortable hearing experience. If you or a loved one is considering hearing aids, consult with a hearing care professional at Ear Solutions hearing aid clinic in Mumbai to explore the benefits of binaural hearing and determine the best solution for your hearing needs. Embracing binaural hearing can lead to a richer, more engaging auditory experience and significantly improve your quality of life.
1. Stem Cell Clinic Injunction
By: Song Seto, Ph.D.
The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to
work with the Agency and understand the regulatory framework. Will it work this time around?
This blog article recaps how we got to this point.
Stem cell treatments have been gaining popularity globally. Research is progressing in this field,
but it is not fast enough for some. There is a rise in stem cell treatments being offered for
debilitating conditions such as Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and
chronic obstructive pulmonary disease. However, there are many cases of unsubstantiated
claims being made that are causing irreparable harm. For example, there is the notorious case of
U.S. Stem Cell, who conducted a fee-for-service treatment in which stem cells derived from fat
were injected into patients suffering from macular degeneration. All 3 patients lost all or most of
their vision. Subsequent investigations showed that the clinic failed to establish and follow
procedures to prevent microbial contamination and refused to permit entry for FDA to conduct
an inspection. Despite a warning letter to U.S. Stem Cell in 2017, the company continued
operations and stem cell treatments. Instead of correcting noted problems, the clinic stated that
FDA did not have authority to regulate the treatment.
On June 3, 2019, a federal judge ruled that FDA is entitled to a permanent injunction against US
Stem Cell, to force the company to halt procedures that isolate stem cells from fat and reinject
them into the patient. Another lawsuit against the Cell Surgical Network is pending. It’s likely
that this will impact businesses that use fat-based stem cell treatments and yet may also drive
businesses to use other sources of stem cells in an individual, such as bone marrow or umbilical
cord blood.
FDA has stipulated that the manner in which cells are collected, processed, and delivered place
them under the regulatory category of a drug. FDA has been trying to encourage stem cell
businesses to work with the Agency rather than become litigious. In 2017, FDA gave stem cell
businesses a 3-year grace period to engage with FDA to understand how they might come into
compliance, whether for investigational trials or premarket approval requirements. However, the
rate for those offering human cells, tissues, and cellular- and tissue-based products, to come into
compliance has been slower than expected. So, FDA is offering a temporary program for
manufacturers to get quick, informal, non-binding assessment from FDA. “Tissue Reference
Group (TRG) Rapid Inquiry Program (TRIP)” intends to respond to inquiries that contain
sufficient detail within 3 days of receipts. The program will be available until December 31,
2019.
2. Page 2 of 2
The TRIP provides a preliminary, informal, non-binding assessment based on evaluation of the
following information, where provided:
1. The manufacturer of the product, if other than requester.
2. The source of the product, including whether it is autologous or allogeneic.
3. A clear, step by step description of how the product is processed from the time of
recovery to the point of use.
4. The specific way(s) the product is to be used and route of administration.
5. Description of any device or apparatus (e.g., syringe) required to deliver the HCT/P to the
recipient.
The opportunity to get feedback from FDA, and in such an expedited manner, is advantageous,
but it is unclear how successful the program will be. There is indication that some stem cell
clinics would rather move overseas to avoid regulation. That may accelerate when the grace
period ends in November 2020.
Interested in additional information on this topic? Please contact us at (248) 987-4497 or
info@emmainternational.com.