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.
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.
As medical understanding of the genotype/phenotype correlation of a disease becomes clearer, genetic testing can be expected to become a mainstay in the clinical setting. While the application of genetic testing to the clinical setting is very much in line with the larger medical goals of preventative and personalized medicine, there are many unanswered questions with regard to genetic testing.
Speakers: Dr. Mansoor Mohammed, Genomics Portraits Inc., Dr. Brian Underdown, Managing Director, MDS Capital, Dr. June Carroll, Sydney G. Frankfort Chair in Family Medicine Mt.Sinai Hospital, Dr. Peter N. Ray, Head, Molecular Genetics Department of Paediatric Laboratory Medicine. HSC Professor, Molecular and Medical Genetics, University of Toronto
Using Clinical Studies to Support Claims for 510(k) Devices. Michael Swit
Presentation to the Regulatory Affairs Professionals Society (RAPS) Advertising, Promotion and Labeling Conference, May 2, 2006, Denver, with a focus on:
• Clinical Literature to Support Claims in Labeling and Advertising –FDA’s Views
• Clinical Investigations–using to Support Claims in Labeling and Advertising
• “Intended Use”–the Lynchpin of Device Promotional Analysis vis-à-vis Clinical Studies
• Case studies --Advertising/Promotional Claims Impacted by Deviations from Intended Use
• A Final Word of Caution –Be Careful if You Are Publicly Traded on what you say on clinicals
Compliance shall never be the sole focus of GXP readiness preparations. Risks to business are numerous and varied and need to be considered in a holistic manner.
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.
As medical understanding of the genotype/phenotype correlation of a disease becomes clearer, genetic testing can be expected to become a mainstay in the clinical setting. While the application of genetic testing to the clinical setting is very much in line with the larger medical goals of preventative and personalized medicine, there are many unanswered questions with regard to genetic testing.
Speakers: Dr. Mansoor Mohammed, Genomics Portraits Inc., Dr. Brian Underdown, Managing Director, MDS Capital, Dr. June Carroll, Sydney G. Frankfort Chair in Family Medicine Mt.Sinai Hospital, Dr. Peter N. Ray, Head, Molecular Genetics Department of Paediatric Laboratory Medicine. HSC Professor, Molecular and Medical Genetics, University of Toronto
Using Clinical Studies to Support Claims for 510(k) Devices. Michael Swit
Presentation to the Regulatory Affairs Professionals Society (RAPS) Advertising, Promotion and Labeling Conference, May 2, 2006, Denver, with a focus on:
• Clinical Literature to Support Claims in Labeling and Advertising –FDA’s Views
• Clinical Investigations–using to Support Claims in Labeling and Advertising
• “Intended Use”–the Lynchpin of Device Promotional Analysis vis-à-vis Clinical Studies
• Case studies --Advertising/Promotional Claims Impacted by Deviations from Intended Use
• A Final Word of Caution –Be Careful if You Are Publicly Traded on what you say on clinicals
Compliance shall never be the sole focus of GXP readiness preparations. Risks to business are numerous and varied and need to be considered in a holistic manner.
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
ICIC 2014 Patent Landscape Analysis as a Tool for Public Policies Adjustment:...Dr. Haxel Consult
The innovative multinational pharmaceutical industry is highly dependent on the release and promotion of new drugs. However, recent economic evidence demonstrates a continuing decrease in new drugs’ market approval. Moreover, the industry is challenged by the “patent cliff”, where many blockbuster drugs are losing patent protection and facing ferocious competition.
It seems that the shortage of new drugs points to an intensification of drug development based on molecules already known, leading to incremental patents. However, there is a suspicion that many incremental patents are actually trivial, because they add little or nothing to existing therapies, but still impose high drug costs. To analyze that hypothesis, the present study has drawn the profile of all patents filed in Brazil in the antiretroviral (ARV) field up to 2012. Using VantagePoint® and Questel Orbit® softwares, a patent matrix was constructed with quali-quantitative data. Next, the patent applications' claims were analysed in order to detect incremental patents and classified according to their incrementalities. Finally we looked for evidence of triviality. As a result, it was demonstrated that the ARV market is highly concentrated and patent applications basically belong to six countries. Evidence that many incrementalities are actually trivialities and act as entry barriers, was found. Patent landscape studies such as this one can be extrapolated to other areas or countries, and can be used as a tool for public policy’s analysis to really fuel technological advance.
Catheters are used in a number of processes, such as: cardiovascular, urological, intravenous, oximetry, thermodilution, suction and wound drainage processes, that involve the administration or drainage of fluids from the body. The global market for catheters is vibrant and continually evolving with significant investments to improve the capabilities of existing catheters, improve safety features and identify new medical applications. The growing number of aged people undergoing diagnostic and therapeutic procedures is driving increases in catheter sales. Government regulations also play a key role, mainly in the urological catheter segment, as regulations attempt to promote fewer infections among hospitalized patients through more frequent use of catheterization. This TriMark Publications report provides a detailed analysis of the global market for catheters, including central venous catheters (CVC), peripheral venous catheters (PVC), midline catheters (MC), hemodialysis catheters, pulmonary artery catheters, peripheral artery catheters and umbilical catheters. The study also analyzes almost all of the companies known to be marketing, manufacturing or developing catheter products in the U.S. and worldwide. Detailed tables, charts and figures are included with projected sales data by geographic region for the Americas, EMRA (Europe, the Middle East, Russia, Africa) and Asia-Pacific regions.
Availability of essential medicines in Hungary (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in Hungary. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern. Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost-effectiveness of the medicines.
Coronary Disease Global Clinical Trials Review, H1, 2012ReportLinker.com
Coronary Disease Global Clinical Trials Review, H1, 2012
Summary
GlobalData's clinical trial report, 'Coronary Disease Global Clinical Trials Review, H1, 2012" provides data on the Coronary Disease clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Coronary Disease. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Coronary Disease. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
Preparing Project Managers for Biotechnology (Arthur Miodozeniec PhD) April 2004
Dr Mlodozeniec, passed away in 2006, he was wonderful professor, rigorously taught us many critical skills, on risk management. Here reverse and forward engineering XL 119. Google his obituary.
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
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
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
ICIC 2014 Patent Landscape Analysis as a Tool for Public Policies Adjustment:...Dr. Haxel Consult
The innovative multinational pharmaceutical industry is highly dependent on the release and promotion of new drugs. However, recent economic evidence demonstrates a continuing decrease in new drugs’ market approval. Moreover, the industry is challenged by the “patent cliff”, where many blockbuster drugs are losing patent protection and facing ferocious competition.
It seems that the shortage of new drugs points to an intensification of drug development based on molecules already known, leading to incremental patents. However, there is a suspicion that many incremental patents are actually trivial, because they add little or nothing to existing therapies, but still impose high drug costs. To analyze that hypothesis, the present study has drawn the profile of all patents filed in Brazil in the antiretroviral (ARV) field up to 2012. Using VantagePoint® and Questel Orbit® softwares, a patent matrix was constructed with quali-quantitative data. Next, the patent applications' claims were analysed in order to detect incremental patents and classified according to their incrementalities. Finally we looked for evidence of triviality. As a result, it was demonstrated that the ARV market is highly concentrated and patent applications basically belong to six countries. Evidence that many incrementalities are actually trivialities and act as entry barriers, was found. Patent landscape studies such as this one can be extrapolated to other areas or countries, and can be used as a tool for public policy’s analysis to really fuel technological advance.
Catheters are used in a number of processes, such as: cardiovascular, urological, intravenous, oximetry, thermodilution, suction and wound drainage processes, that involve the administration or drainage of fluids from the body. The global market for catheters is vibrant and continually evolving with significant investments to improve the capabilities of existing catheters, improve safety features and identify new medical applications. The growing number of aged people undergoing diagnostic and therapeutic procedures is driving increases in catheter sales. Government regulations also play a key role, mainly in the urological catheter segment, as regulations attempt to promote fewer infections among hospitalized patients through more frequent use of catheterization. This TriMark Publications report provides a detailed analysis of the global market for catheters, including central venous catheters (CVC), peripheral venous catheters (PVC), midline catheters (MC), hemodialysis catheters, pulmonary artery catheters, peripheral artery catheters and umbilical catheters. The study also analyzes almost all of the companies known to be marketing, manufacturing or developing catheter products in the U.S. and worldwide. Detailed tables, charts and figures are included with projected sales data by geographic region for the Americas, EMRA (Europe, the Middle East, Russia, Africa) and Asia-Pacific regions.
Availability of essential medicines in Hungary (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in Hungary. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern. Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost-effectiveness of the medicines.
Coronary Disease Global Clinical Trials Review, H1, 2012ReportLinker.com
Coronary Disease Global Clinical Trials Review, H1, 2012
Summary
GlobalData's clinical trial report, 'Coronary Disease Global Clinical Trials Review, H1, 2012" provides data on the Coronary Disease clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Coronary Disease. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Coronary Disease. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
Preparing Project Managers for Biotechnology (Arthur Miodozeniec PhD) April 2004
Dr Mlodozeniec, passed away in 2006, he was wonderful professor, rigorously taught us many critical skills, on risk management. Here reverse and forward engineering XL 119. Google his obituary.
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
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
Medical device regulation is complex, in part because of the wide variety of items that are categorized as medical devices.
They may be simple tools used during medical examinations,
such as tongue depressors and thermometers, or high-tech life-saving devices that are implanted in the patient, like pacemakers and coronary stents.
The federal agency responsible for regulating medical devices is the Food and Drug
Administration (FDA)—an agency within the Department of Health and Human Services (HHS).
A manufacturer must obtain FDA’s prior approval or clearance before marketing many medical
devices in the United States.
FDA’s Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device premarket review.
Another center, the Center for Biologics Evaluation and Research (CBER), regulates devices associated with blood collection and processing procedures, cellular products and tissues.
Under the terms of the Medical Device Amendments of 1976
FDA classified all medical devices that were on the market at the time of enactment— the Pre amendment devices—into one of three classes.
Congress provided definitions for the three
classes—Class I, Class II, and Class III—based on the risk (low-, moderate-, and high-risk
respectively) to patients posed by the devices.
A PMA is “the most stringent type of device marketing application required by FDA” for new and/or high-risk devices.
PMA approval is based on the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s)
PMAs generally require some clinical data prior to FDA making an approval decision.
All clinical evaluations of investigational devices (unless exempt) must have an investigational device exemption (IDE) before the clinical study is initiated.
An IDE allows an unapproved device (most commonly an invasive or life-sustaining device) to be used in a clinical study to collect the data required to support a PMA submission.
The IDE permits a device to be shipped lawfully for investigation of the device without requiring that the manufacturer comply with other requirements of the FFDCA, such as registration and listing.
A PMA must contain (among other things) the following information:
summaries of nonclinical and clinical data supporting the application and conclusions drawn from the studies;
a device description including significant physical and performance characteristics;
indications for use, description of the patient population and disease or condition that the device will diagnose, treat, prevent, cure, or mitigate;
a description of the foreign and U.S. marketing history, including if the device has been withdrawn from marketing for any reason related to the safety or effectiveness of the device;
proposed labeling; and
a description of the manufacturing process.
If a manufacturer wants to make a change to an approved PMA device.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Crossroads: U.S. Medical Device Regulation vs. Innovation
The U.S. medical device industry is at a regulatory and potentially economic crossroad as the FDA continues to refine its 510(k) regulatory submission requirements and guidelines. Medical device manufacturers have been urging the FDA and Congress to expedite new product review processes to spur innovation and bring new medical technologies to market faster. However, supporters of stricter FDA regulations claim that a faster regulatory review process causes unsafe devices to enter the market.
As a result of numerous exchanges between both sides of the issue, CDRH (FDA) recently issued multiple updates to its initiatives for the 510(k) approval process. To shed light on key changes, we obtained the support of the office of Dr. Jeffrey Shuren MD JD, Director of CDRH and Dr. John Smith MD JD, of Hogan Lovells, a prominent international law firm with a medical regulatory specialty, on their interpretations of the 510(k) regulatory guidelines and the impact these guidelines will have on medical device manufacturers.
Listen to the Dr. John Smith podcast interview here:
http://youtu.be/iHVpwwXi7dY
The MarkeTech Group
502 Mace Blvd.
Davis, CA 95618
http://www.themarketechgroup.com
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)
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
Patient engagement in medical device studiesCOUCH Health
Not only will the industry see changes with the EU MDR, but we're glad that patients will recognise changes for the better, too. Patients can expect to make more informed decisions before using medical devices, as more information will become publicly available. And we think this is a big step in the right direction! Read more about our thoughts on involving patients more in the medical device clinical trial process:
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
EMA Guidelines for Clinical Trial Management - Pepgra HealthcarePEPGRA Healthcare
The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. EMA guidelines for clinical trial regulations adopted in 2014 aim to make it easier for the clinical trials companies while empowering participants through transparency.
Continue Reading : http://bit.ly/36LJZa7
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
Whatsapp: +91 9884350006
4. Use α=.01, and n=100Determine the Chi-Square value, and come to.docxgilbertkpeters11344
4. Use α=.01, and n=100Determine the Chi-Square value, and come to the appropriate conclusion concerning this goodness of fit procedure.
*From the Table of Random Numbers…all have a probability of 1/10 “numbers from 0-9”
Number
Observed
Expected
0
5
10
25
2.5
1
15
10
25
2.5
2
10
10
0
0
3
8
10
4
0.4
4
12
10
4
0.4
5
15
10
25
2.5
6
5
10
25
2.5
7
10
10
0
0
8
10
10
0
0
9
10
10
0
0
Total
100
100
108
10.8
5. Construct a confidence interval for σ2 using the following values of the variable, X. You may assume that the variable itself is normally distributed.
X
30
32
28
25
31
34
30
20
40
A. let alpha be .01, and construct the confidence interval.
B. Now let alpha be .10, and again construct the confidence interval.
C. Why did we have to assume that the variable itself was normally distributed?
1
310 week 5 Response:
Response needed to each Post! I have listed an example of a “response” in RED. There are four “post” total that need responses.
· Post: Lisa Kaufman posted Nov 17, 2015 1:21 PM
The Medical Device Safety Act (MDSA)
I found this “ACT/LAW” very much and advocate for the patient….The Medical Device Safety Act (MDSA) was implemented in 2009. This law will restore patients’ ability to hold medical device manufacturers accountable for injuries caused by defective medical devices. Medical devices range from catheters, implantable defibrillators, pacemaker wires and artificial heart valves.
“Although, the bill replies to a 2008 Supreme Court decision, Riegel v. Medtronic.” That case held that a medical device manufacturer usually cannot be sued by injured patients if the Food and Drug Administration (FDA) approved the device for marketing through its premarket approval (PMA) process.
This bill has two important goals;
▪Improved Recall Processes: This bill has implantation to have the Government Accountability Office (GAO) to improve the handling on the FDA’s recall of defective devices. The GAO will require the FDA to assess and revaluate each device that falls under the unsafe device and expedite the recalls once the “problem” is discovered.
▪ Enhance Post-Market Surveillance Tools: “This legislation would improve FDA’s ability to conduct post-market surveillance for 510(k) cleared devices by allowing FDA to require the collection of post-market data as a condition of approval.” “The authority would mirror the post-market studies that can be required as a condition of a Pre-Market Approval (PMA) for highest risk devices. Under this legislation, the FDA could require conditions of clearance for 510(k) cleared devices that may have safety concerns. If FDA found a device substantially equivalent to a predicate for a higher-risk device, FDA could clear the device for market through 510(k) but require companies to conduct clinical studies and collect and report more complete data”.
Background
FDA’s oversight of medical devices has landed the agency on GAO’s “high-risk list”.2 GAO cites its concerns about FDA’s post-ma.
Patient Advocate Stephen Dolle's FDA Stamp Conference RecommendationsStephen Dolle
This is a paper of FDA STAMP Conference recommendations FDA patient advocate and CNS shunt user Stephen Dolle, which he wrote for this 1999 Conference in Bethesda, MD, a conference he was responsible for, yet was not invited to speak on panel, nor was his new solution oriented DiaCeph Test included in the conference. STAMP was held in part due to Dolle's 1996 FDA petition on anti siphon shunts, of which he was an affected user, and FDA upheld, but oddly withheld their Sept. 1998 ruling from the Federal Register. Dolle did everything he could possibly do to bring progress in CNS shunts, yet wasn't allowed.
You can read from his recommendations back in 1999 that he had a vision to bring progress in this area. Since 1999, CNS shunts have been plagued by widespread device failures, more notably programmable shunts.
CNS shunts users today face new risks from years of over use of CT scanning, which DiaCeph would have reduced. Some patients have had as many as 100 and 200.
I can be reached at contact[at]dollecommunications[dot]com and via my blog.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Pharma Pcd Franchise in Jharkhand - Yodley Lifesciences
Medical device regulation
1. EDITORIAL
Rethinking medical device
regulation
Carl Heneghan • Mathew Thompson
Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
Correspondence to: Carl Heneghan. Email: carl.heneghan@phc.ox.ac.uk
DECLARATIONS Complications with Poly Implant Prosthese (PIP) regulatory process in the USA, fewer than
breast implants1 and Metal on Metal (MoM) hip one-third had undergone randomized trials and
Competing interests
implants2 reflect systemic failings with the only half of the trials overall involved controls.8
None declared
current regulation of medical devices. Yet, these Whilst new drugs require at least randomized
Funding two cases highlight only a fraction of the burgeon- controlled trials to gain regulatory approval, for
The authors
ing increase in medical device safety alerts3 and medical devices even under the more stringent
problems with device recalls, and are leading to PMA approval process, only one controlled trial
received no funding
a rethink of the systems for regulatory approval (not necessarily randomized trial) is required.
Ethical approval in both Europe and the USA.4 However, an even more worrying issue with
Not required Therefore, having an understanding of medical device regulation in both the EU and US is the
device regulation is now an important require- use of ‘substantially equivalent’ in evidence sub-
Guarantor ment for doctors and healthcare professionals missions for regulatory purposes. The problems
Carl Heneghan alike. To aid this, French-Mowatt and colleagues with using ‘equivalence’ in the device approval
summarize the current medical device regulation process can be traced back several decades. In
Contributorship
in Europe,5 outlining the current requirements 1976, in the USA many devices were already on
Both CH and MT for CE regulation. Outside of the European the market, so a less burdensome alternative to
contributed to the Union, Susan Lamph describes the regulatory pro- PMA known as 510(k) provision was approved.
ideas, drafted the cesses across different countries and the lack of The 510(k) pathway did not require clinical
manuscript and harmonization with leads to wide variation in pre- trials; the manufacturer was only required to
approved the final market data requirements.6 demonstrate a device was ‘substantially equival-
version Analysis of medical-device recalls in the UK ent’ to another device already on the market. The
and the USA, and the device-regulation process, problem now is that the definition of equivalence
Acknowledgments reveals the increasing nature of the problems. is interpreted so loosely that the FDA admits
None From 2006 to 2010, the UK regulator, the MHRA they need to ‘clarify the meaning of “substantial
issued 2,124 manufacturer field safety notices, an equivalence.”’10
increase of 1,220% over this five-year period.3 In The predicate of equivalence is also used
the USA the number of recalls for moderate or within the European Union (EU) regulatory
high-risk devices more than doubled between system for device regulation. There are three Euro-
2007 to 2011.7 In addition, many recalled medical pean Directives related to device regulation.11 – 13
devices in the USA were originally cleared using These directives, which lead to CE marking and
a less stringent process called 510(k), or even access to the European market, state the extent
more problematic, recalled devices were con- and nature of clinical data required for approval.5
sidered to be so low-risk they were exempt from Problems occur because even for implantable
regulatory review in the first place. This situation devices, the scrutiny of evidence at the outset is
reflects a very low ‘bar’ currently for evidence left to private organizations known as Notified
requirements to gain regulatory approval, even Bodies;3 and secondly, clinical data required for
for high-risk devices. For instance, of 78 high-risk the equivalent route can involve as little as ‘a criti-
cardiovascular devices approved through the cal evaluation of the relevant scientific literature
more stringent Pre-Market Approval (PMA) currently available relating to the safety,
186 J R Soc Med 2012: 105: 186 –188. DOI 10.1258/jrsm.2012.12k030
2. Rethinking Medical Device regulation
performance, design characteristics and intended without a substantial battle with the medical
purpose of the device’. The use of equivalence is device industry.
therefore left to the manufacturer and the Notified Sprange and Clift’s analysis of manufacturers’
Bodies to determine, without any outside scrutiny submission challenges, to the NICE medical
of the decision making process centrally or within technology program, in the supplement edition
each EU country. J R Soc Med 2012;105 (S1) reveals there are
Even for the more stringent PMA process, there significant issues in relation to basic and general
are profound differences in evidence requirements research skills that need to be addressed
between the US and EU. For example, EU amongst manufacturers.17 In addition, interviews
approval of a ‘GuardWire’ developed by Percu- with manufacturers highlight the current status
Surge for use during angioplasty, required a 22 quo: ‘pharmaceutical and medical technologies
patient study with no control group. Yet, in the were also considered very different by manufac-
USA, FDA regulators required an 800 patient mul- turers.’ As such, the widespread belief is that
ticentre randomized controlled trial.14 devices do not require the same level of evidence
Perhaps what is even more concerning than the as drugs to gain access to a market and be used
device recalls and high profile cases (such as the in clinical practice. Sprange’s study highlights
MoM hips and PIP implants), is that many the need for education and research ‘tools,’
medical device problems go unnoticed. For which will facilitate higher quality evidence sub-
example, women participating in a breast cancer missions for approval in the future.
study were left with hundreds of tiny particles of The European Directive on medical devices
the heavy metal tungsten in their breast tissue will be revised later this year. The European Com-
due to a faulty device cleared under the 510(k) mission has stated it will use this opportunity to
processes.9 Similarly, recalled device notices strengthen existing legislation, particularly pro-
often go unheeded. In 2006 the maker of a surgical visions relating to market surveillance, vigilance
clip, the Hem-o-lok issued an urgent recall notice and the functioning of notified bodies. In the
warning surgeons to stop using the clips on living UK, the House of Commons Science and Technol-
kidney donors. However, three years later a ogy Committee plans to examine whether current
surgeon used one of the clips to tie off a 29-year- legislation and regulations on safety and efficacy
old male’s renal artery during an operation in of medical implants are fit for purpose.18
which he donated a kidney to his wife. He bled Failures of medical devices cause harm and
to death twelve hours later when the clip malfunc- cost money. More stringent requirements to
tioned.10 – 15 Currently we have limited ability to provide evidence from clinical trials for the effi-
trace most patients in whom medical devices cacy and safety medical devices before they are
have been used (or implanted), so when problems approved should therefore be welcomed by
or recalls occur, it can be impossible to know the patients, clinicians and the medical device indus-
magnitude of the problem. try. Evidence for new devices must also be open
However, it seems as though the tide is to scrutiny by patients in individual countries, as
turning in terms of regulatory requirements. well as healthcare providers and researchers. The
The American system is coming under increased potential risk of a new device should match the
scrutiny with calls for the removal of the 510(k) type of evidence required prior to approval for
process. The influential Institute of Medicine use in clinical settings. Without these changes to
has recommended the FDA do away with the current systems, it is likely we will continue to
510(k) approval process and replace it ‘with an see substantial complications arising from faulty
integrated premarket and post-market regulatory devices.
framework that effectively provides a reasonable
assurance of safety and effectiveness throughout
the device life cycle.’16 It is possible that all
References
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PMA approval and thus clinical trial data in
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are unlikely to be passed into law in the US with metal-on-metal hip implants. BMJ 2012;344:e1349
J R Soc Med 2012: 105: 186 –188. DOI 10.1258/jrsm.2012.12k030 187
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