FDA regulates the labeling and advertising of all pharmaceutical products; however, it regulates the labeling of all medical devices and the advertising of only restricted devices...
The document summarizes an introduction to the FDA Social Media Hearing (FDASM). It provides background on the purpose of the hearing, which is to get public input on how expanded web technologies can be used to promote medical products to healthcare professionals and consumers in a truthful manner, and on internet adverse event reporting. The main questions to be addressed at the hearing are about accountability, regulatory requirements for social media promotion, corrective information on third party sites, appropriate use of links, and adverse event reporting. Highlights from a previous forum on related issues are also summarized.
Social Media and Adverse Events Reporting / Pharma Customer Experience Manage...Piotr Wrzosinski
Dealing with side effects is reported by patients as the second most frustratiin part of their treatment experience (PwC 2013 Customer Exerience Radar Research). This presentation looks at
- regulatory obligations of pharmaceutical firms in AER and DTC communication
- social media as a medium to discover and report adverse events
- recent research on the occurence of reportable adverse events in social media space
- regulatory agencies (FDA, EMA) pharmacovigilance activities in Social Media
- algorithm to track adverse events with industry standard social media monitoring tools
- possible engagement with the patients to address side effects and increase treatment adherence within regulatory boundaries
Adverse Event Reports for Devices Under an EUAEMMAIntl
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-19. Much like other medical devices that follow a more routine regulatory pathway, devices under an EUA must still comply with 21 CFR 803, including the submission of medical device reports (MDR’s) for reportable adverse events. This regulatory requirement may not be explicitly clear to many of the non-med device firms that stepped into the ring like Ford and Tesla...
Kyrgyzstan faces several issues related to access to medicines, including limited affordability and availability, especially of medicines for chronic diseases. There is also a problem with low quality medicines entering the country through informal channels. The MeTA program in Kyrgyzstan aims to address these issues by improving information sharing between organizations, disseminating information to the public, and encouraging collaboration between the government, private sector, and civil society organizations.
As the spread of the 2019 Coronavirus Disease (COVID-19) continues to grow globally, the FDA and other global health organizations have had to put precautions in place to protect the public...
Research aarkstore enterprise biomarker technology platforms for cancer diag...Neel Terde
This document summarizes a report by Aarkstore Enterprise on biomarker technology platforms for cancer diagnoses and therapies. It discusses how biomarkers can aid in early detection and diagnosis of cancer as well as monitoring disease progression and treatment efficacy. The report examines clinical devices, reagents, and supplies used in hospitals and clinics to diagnose and monitor cancer through biomarkers. It also discusses how biomarkers help in developing novel targeted cancer therapeutics and predicting their effectiveness.
The document summarizes an introduction to the FDA Social Media Hearing (FDASM). It provides background on the purpose of the hearing, which is to get public input on how expanded web technologies can be used to promote medical products to healthcare professionals and consumers in a truthful manner, and on internet adverse event reporting. The main questions to be addressed at the hearing are about accountability, regulatory requirements for social media promotion, corrective information on third party sites, appropriate use of links, and adverse event reporting. Highlights from a previous forum on related issues are also summarized.
Social Media and Adverse Events Reporting / Pharma Customer Experience Manage...Piotr Wrzosinski
Dealing with side effects is reported by patients as the second most frustratiin part of their treatment experience (PwC 2013 Customer Exerience Radar Research). This presentation looks at
- regulatory obligations of pharmaceutical firms in AER and DTC communication
- social media as a medium to discover and report adverse events
- recent research on the occurence of reportable adverse events in social media space
- regulatory agencies (FDA, EMA) pharmacovigilance activities in Social Media
- algorithm to track adverse events with industry standard social media monitoring tools
- possible engagement with the patients to address side effects and increase treatment adherence within regulatory boundaries
Adverse Event Reports for Devices Under an EUAEMMAIntl
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-19. Much like other medical devices that follow a more routine regulatory pathway, devices under an EUA must still comply with 21 CFR 803, including the submission of medical device reports (MDR’s) for reportable adverse events. This regulatory requirement may not be explicitly clear to many of the non-med device firms that stepped into the ring like Ford and Tesla...
Kyrgyzstan faces several issues related to access to medicines, including limited affordability and availability, especially of medicines for chronic diseases. There is also a problem with low quality medicines entering the country through informal channels. The MeTA program in Kyrgyzstan aims to address these issues by improving information sharing between organizations, disseminating information to the public, and encouraging collaboration between the government, private sector, and civil society organizations.
As the spread of the 2019 Coronavirus Disease (COVID-19) continues to grow globally, the FDA and other global health organizations have had to put precautions in place to protect the public...
Research aarkstore enterprise biomarker technology platforms for cancer diag...Neel Terde
This document summarizes a report by Aarkstore Enterprise on biomarker technology platforms for cancer diagnoses and therapies. It discusses how biomarkers can aid in early detection and diagnosis of cancer as well as monitoring disease progression and treatment efficacy. The report examines clinical devices, reagents, and supplies used in hospitals and clinics to diagnose and monitor cancer through biomarkers. It also discusses how biomarkers help in developing novel targeted cancer therapeutics and predicting their effectiveness.
The unemployment rate nationally was 8.8% in April 2011. Unemployment for those with a bachelor's degree or higher was 4.4%. The unemployment rate for management, business, and financial occupations was 4.8%.
A study found that less than 40% of hospitals posted on their Facebook page daily and about 80% failed to utilize the discussion board, not taking full advantage of social media to engage patients and communities.
A $3 million prize will be awarded for the algorithm that can best predict when patients are at risk for hospital admissions, which could help reduce unnecessary hospitalizations through improved care plans.
When families moved to health plans with deductibles over $1,000, health spending dropped
Use of testimonials and endorsements in prescription drug advertisementsFreedom Monk
This document discusses the use of testimonials and endorsements in prescription drug advertising. It notes that while endorsements are widely used, they carry risks of being misleading if they overstate a drug's efficacy, minimize risks, or make unsupported claims. The FDA and FTC provide guidance on appropriate use of endorsements. Key points are that endorsements must be supported by substantial evidence and consistent with drug labeling. Risk information must also be adequately presented. Companies should verify endorsers' actual experience with the promoted drug. Statements cannot represent unsupported quality of life claims or overstate duration of efficacy. The FDA has taken enforcement action against misleading endorsements.
A newsletter roundup featuring recent stories including how Snapchat is facing a lawsuit from an injured driver, updates on the Aliso Canyon gas leak, and a product liability lawsuit against device manufacturer Intuitive Surgical Inc.
Remote patient monitoring devices market is estimated to increase to us$ 1,50...Rakesh Zanje
MRRSE has announced the addition of the “Global Market Study on Remote Patient Monitoring Devices: Cardiac Monitors Product Type Segment to Account for 50.9% Market Revenue Share by 2024” report to their offering.
Digitas Health released the results of its research into how European doctors, patients and caregivers use social media for information, education and support. The results were explained at a pharmaceutical marketing conference, ThinkDigital 2010, held by Digitas Health in London on March 25, 2010.
This document provides information about a market research report on the global patient monitoring devices market. The 334-page report, published in February 2015, analyzes the $24.3 billion global patient monitoring devices market, covering device types, end users, regions, company profiles, and market projections. It finds that patient monitoring plays a key role in healthcare, with cardiac monitoring currently dominating but neurological and respiratory monitoring growing the fastest. The full report can be purchased for prices ranging from $4,500 to $9,000 depending on license type.
The document summarizes feedback from stakeholders on AstraZeneca's submission to the FDA regarding social media engagement in the pharmaceutical industry.
Key discussion points included that social media is important for advancing public health, and pharmaceutical companies have a responsibility to engage more in social media. Stakeholders provided feedback on the FDA's role as regulator, noting social media requires a tailored approach, and companies can help address misinformation online. They also covered pharmaceutical companies' role, emphasizing the need for ongoing dialogue and mutual agreement with patients/caregivers.
This document discusses online communication channels between physicians and pharmaceutical/biotech companies. It finds that physicians are increasingly seeking information digitally and face-to-face meetings with sales reps are declining. Videoconferencing and online content are promising new channels. Physicians are comfortable with various media formats and expect on-demand access across channels. The document also provides an overview of the ePharma Physician product which analyzes physician behaviors and preferences around digital engagement.
Vichara Health aims to develop the standard for quantifying patient harm in hospitals. Their Intelligent Error Surveillance system uses machine learning to scan discharged patient records, identify errors and near misses, and provide a comprehensive picture of safety issues, as a clinician would during chart review. This helps hospitals more efficiently monitor patient safety compared to traditional voluntary reporting methods. The system gives hospitals complete and controlled error surveillance to help improve care quality.
On numerous occasions, we have seen companies’ websites and products boasting with an FDA approved stamp on it. While the FDA is responsible for protecting public health by regulating drugs, medical devices, tobacco, food, cosmetics, and radiation-emitting products; it does not approve all products in the categories above...
Medical devices keep evolving, and with cutting edge technologies such as AI and Cloud, they are continuously adding quality to the overall patient care. Being in the medical sector, where the patient and their care is always a priority, manufacturers are required to follow the FDA regulatory guidelines which ensure that their devices are qualified enough to be released in the market. When it comes to FDA approval, it is essential to know the class of the device. The device class is one factor in determining the regulatory pathway and therefore, identifying the medical device class is a vital first step in the FDA medical device approval process...
Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. September 25, 2013
http://www.alfonsogadea.es/apps-salud-poniendo-orden/
This document provides guidance for industry and FDA staff on mobile medical applications (mobile medical apps). It defines key terms related to mobile platforms, mobile apps, and mobile medical apps. Mobile medical apps are a subset of mobile apps that meet the definition of a medical device and are subject to FDA regulatory oversight if they could pose risks to patient safety if not functioning properly. The guidance outlines the FDA's approach to regulating mobile medical apps based on their intended use and functionality rather than the platform. It also provides examples of mobile apps that would and would not be regulated as medical devices.
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...CRF Health
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and
potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential
benefits and risks to public health represented by these apps. The FDA is issuing this guidance
document to inform manufacturers, distributors, and other entities about how the FDA intends to
apply its regulatory authorities to select software applications intended for use on mobile
platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad
applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.
FDA the Gold Standard for Medical Device SafetyEMMAIntl
A year-long investigation titled “Implant Files”, which was initiated by the ICIJ (International Consortium of Investigative Journalists) and involved 250 journalists from 36 countries, was released a few weeks ago...
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Pharma, Social Media, & Mobile A Happy Ménage à Trois?Pharma Guy
The document discusses pharmaceutical companies' use of social media and mobile applications. It notes milestones and mistakes in pharma's adoption of these technologies. It also summarizes guidelines from regulatory agencies on topics like adverse event reporting, off-label promotion, and editing drug information online. Survey results show most agree self-regulation is needed for mobile medical apps. The document provides resources for assessing social media readiness and best practices in mobile health.
Navigating FDA’s Social Media Guidelines for Medical Devices.pdfdnyaneshwarivedpatha1
Ensuring Regulatory Compliance and Monitoring in Medical Device Marketing
Compliance and Monitoring
FDA’s Stance on Continued Monitoring of Third-Party Websites and Social Media Platforms
The FDA emphasizes the importance of continued monitoring of third-party websites and social media platforms by medical device companies. This monitoring helps ensure that information related to their products remains accurate, up-to-date, and compliant with regulatory guidelines. Companies are responsible for actively monitoring user-generated content and addressing any misleading or inaccurate information promptly.
Non-Objection to Voluntary Corrections Meeting FDA’s Recommendations
The FDA encourages voluntary corrections by medical device companies to address misinformation or inaccuracies in their marketing materials. When companies take proactive steps to correct such information in line with FDA’s recommendations, the agency generally does not object to these corrective actions. This reflects a collaborative approach between regulatory authorities and industry stakeholders to uphold transparency and accuracy in marketing communications.
Reminder for Companies to Comply with Applicable Regulatory Requirements in Corrective Actions
Medical device companies must ensure that their corrective actions comply with all applicable regulatory requirements set forth by the FDA. This includes providing truthful and non-misleading information, adhering to labeling guidelines, and disclosing affiliations or relationships related to corrective information. Compliance with these requirements is essential to maintain ethical standards and regulatory compliance in marketing practices.
Recommendation for Companies to Maintain Records for Potential FDA Inquiries
As part of regulatory compliance, companies are advised to maintain detailed records of their marketing activities, corrective actions, and communications related to their medical devices. These records serve as evidence of compliance with FDA guidelines and can be valuable in addressing potential inquiries or audits by the FDA. Proper record-keeping demonstrates transparency, accountability, and a commitment to regulatory compliance within the medical device industry.
By adhering to these compliance and monitoring practices, medical device companies can uphold regulatory standards, address misinformation effectively, and maintain trust and credibility among consumers and regulatory authorities alike.
Navigating FDA Guidelines: Best Practices for Medical Device Advertising
Conclusion and Recommendations
Recap of Key Points from FDA’s Proposed Guidelines and Relevant Regulations
Throughout this discussion, we’ve explored the FDA’s proposed guidelines and regulations concerning medical device advertising on social media platforms. Key points include the importance of accurate and balanced communication of benefits and risks, addressing misinformation, and complying with FDA requirements for promotional
This document discusses the current and future potential use of social media in pharmacovigilance (PV). It begins by providing context on the growth of social media and its current uses in biopharmaceutical communication. Regulatory guidance allows for screening of company websites and follow-up of reported safety issues. Currently, social media is primarily used for safety reporting, though opportunities exist to leverage it for data retrieval, analysis, and risk communication. Challenges include validating self-reported social media safety data and ensuring data privacy. Future areas of impact could include establishing social media as an additional reporting channel to increase patient reporting and connect with consumers.
The unemployment rate nationally was 8.8% in April 2011. Unemployment for those with a bachelor's degree or higher was 4.4%. The unemployment rate for management, business, and financial occupations was 4.8%.
A study found that less than 40% of hospitals posted on their Facebook page daily and about 80% failed to utilize the discussion board, not taking full advantage of social media to engage patients and communities.
A $3 million prize will be awarded for the algorithm that can best predict when patients are at risk for hospital admissions, which could help reduce unnecessary hospitalizations through improved care plans.
When families moved to health plans with deductibles over $1,000, health spending dropped
Use of testimonials and endorsements in prescription drug advertisementsFreedom Monk
This document discusses the use of testimonials and endorsements in prescription drug advertising. It notes that while endorsements are widely used, they carry risks of being misleading if they overstate a drug's efficacy, minimize risks, or make unsupported claims. The FDA and FTC provide guidance on appropriate use of endorsements. Key points are that endorsements must be supported by substantial evidence and consistent with drug labeling. Risk information must also be adequately presented. Companies should verify endorsers' actual experience with the promoted drug. Statements cannot represent unsupported quality of life claims or overstate duration of efficacy. The FDA has taken enforcement action against misleading endorsements.
A newsletter roundup featuring recent stories including how Snapchat is facing a lawsuit from an injured driver, updates on the Aliso Canyon gas leak, and a product liability lawsuit against device manufacturer Intuitive Surgical Inc.
Remote patient monitoring devices market is estimated to increase to us$ 1,50...Rakesh Zanje
MRRSE has announced the addition of the “Global Market Study on Remote Patient Monitoring Devices: Cardiac Monitors Product Type Segment to Account for 50.9% Market Revenue Share by 2024” report to their offering.
Digitas Health released the results of its research into how European doctors, patients and caregivers use social media for information, education and support. The results were explained at a pharmaceutical marketing conference, ThinkDigital 2010, held by Digitas Health in London on March 25, 2010.
This document provides information about a market research report on the global patient monitoring devices market. The 334-page report, published in February 2015, analyzes the $24.3 billion global patient monitoring devices market, covering device types, end users, regions, company profiles, and market projections. It finds that patient monitoring plays a key role in healthcare, with cardiac monitoring currently dominating but neurological and respiratory monitoring growing the fastest. The full report can be purchased for prices ranging from $4,500 to $9,000 depending on license type.
The document summarizes feedback from stakeholders on AstraZeneca's submission to the FDA regarding social media engagement in the pharmaceutical industry.
Key discussion points included that social media is important for advancing public health, and pharmaceutical companies have a responsibility to engage more in social media. Stakeholders provided feedback on the FDA's role as regulator, noting social media requires a tailored approach, and companies can help address misinformation online. They also covered pharmaceutical companies' role, emphasizing the need for ongoing dialogue and mutual agreement with patients/caregivers.
This document discusses online communication channels between physicians and pharmaceutical/biotech companies. It finds that physicians are increasingly seeking information digitally and face-to-face meetings with sales reps are declining. Videoconferencing and online content are promising new channels. Physicians are comfortable with various media formats and expect on-demand access across channels. The document also provides an overview of the ePharma Physician product which analyzes physician behaviors and preferences around digital engagement.
Vichara Health aims to develop the standard for quantifying patient harm in hospitals. Their Intelligent Error Surveillance system uses machine learning to scan discharged patient records, identify errors and near misses, and provide a comprehensive picture of safety issues, as a clinician would during chart review. This helps hospitals more efficiently monitor patient safety compared to traditional voluntary reporting methods. The system gives hospitals complete and controlled error surveillance to help improve care quality.
On numerous occasions, we have seen companies’ websites and products boasting with an FDA approved stamp on it. While the FDA is responsible for protecting public health by regulating drugs, medical devices, tobacco, food, cosmetics, and radiation-emitting products; it does not approve all products in the categories above...
Medical devices keep evolving, and with cutting edge technologies such as AI and Cloud, they are continuously adding quality to the overall patient care. Being in the medical sector, where the patient and their care is always a priority, manufacturers are required to follow the FDA regulatory guidelines which ensure that their devices are qualified enough to be released in the market. When it comes to FDA approval, it is essential to know the class of the device. The device class is one factor in determining the regulatory pathway and therefore, identifying the medical device class is a vital first step in the FDA medical device approval process...
Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. September 25, 2013
http://www.alfonsogadea.es/apps-salud-poniendo-orden/
This document provides guidance for industry and FDA staff on mobile medical applications (mobile medical apps). It defines key terms related to mobile platforms, mobile apps, and mobile medical apps. Mobile medical apps are a subset of mobile apps that meet the definition of a medical device and are subject to FDA regulatory oversight if they could pose risks to patient safety if not functioning properly. The guidance outlines the FDA's approach to regulating mobile medical apps based on their intended use and functionality rather than the platform. It also provides examples of mobile apps that would and would not be regulated as medical devices.
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...CRF Health
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and
potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential
benefits and risks to public health represented by these apps. The FDA is issuing this guidance
document to inform manufacturers, distributors, and other entities about how the FDA intends to
apply its regulatory authorities to select software applications intended for use on mobile
platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad
applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.
FDA the Gold Standard for Medical Device SafetyEMMAIntl
A year-long investigation titled “Implant Files”, which was initiated by the ICIJ (International Consortium of Investigative Journalists) and involved 250 journalists from 36 countries, was released a few weeks ago...
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Pharma, Social Media, & Mobile A Happy Ménage à Trois?Pharma Guy
The document discusses pharmaceutical companies' use of social media and mobile applications. It notes milestones and mistakes in pharma's adoption of these technologies. It also summarizes guidelines from regulatory agencies on topics like adverse event reporting, off-label promotion, and editing drug information online. Survey results show most agree self-regulation is needed for mobile medical apps. The document provides resources for assessing social media readiness and best practices in mobile health.
Navigating FDA’s Social Media Guidelines for Medical Devices.pdfdnyaneshwarivedpatha1
Ensuring Regulatory Compliance and Monitoring in Medical Device Marketing
Compliance and Monitoring
FDA’s Stance on Continued Monitoring of Third-Party Websites and Social Media Platforms
The FDA emphasizes the importance of continued monitoring of third-party websites and social media platforms by medical device companies. This monitoring helps ensure that information related to their products remains accurate, up-to-date, and compliant with regulatory guidelines. Companies are responsible for actively monitoring user-generated content and addressing any misleading or inaccurate information promptly.
Non-Objection to Voluntary Corrections Meeting FDA’s Recommendations
The FDA encourages voluntary corrections by medical device companies to address misinformation or inaccuracies in their marketing materials. When companies take proactive steps to correct such information in line with FDA’s recommendations, the agency generally does not object to these corrective actions. This reflects a collaborative approach between regulatory authorities and industry stakeholders to uphold transparency and accuracy in marketing communications.
Reminder for Companies to Comply with Applicable Regulatory Requirements in Corrective Actions
Medical device companies must ensure that their corrective actions comply with all applicable regulatory requirements set forth by the FDA. This includes providing truthful and non-misleading information, adhering to labeling guidelines, and disclosing affiliations or relationships related to corrective information. Compliance with these requirements is essential to maintain ethical standards and regulatory compliance in marketing practices.
Recommendation for Companies to Maintain Records for Potential FDA Inquiries
As part of regulatory compliance, companies are advised to maintain detailed records of their marketing activities, corrective actions, and communications related to their medical devices. These records serve as evidence of compliance with FDA guidelines and can be valuable in addressing potential inquiries or audits by the FDA. Proper record-keeping demonstrates transparency, accountability, and a commitment to regulatory compliance within the medical device industry.
By adhering to these compliance and monitoring practices, medical device companies can uphold regulatory standards, address misinformation effectively, and maintain trust and credibility among consumers and regulatory authorities alike.
Navigating FDA Guidelines: Best Practices for Medical Device Advertising
Conclusion and Recommendations
Recap of Key Points from FDA’s Proposed Guidelines and Relevant Regulations
Throughout this discussion, we’ve explored the FDA’s proposed guidelines and regulations concerning medical device advertising on social media platforms. Key points include the importance of accurate and balanced communication of benefits and risks, addressing misinformation, and complying with FDA requirements for promotional
This document discusses the current and future potential use of social media in pharmacovigilance (PV). It begins by providing context on the growth of social media and its current uses in biopharmaceutical communication. Regulatory guidance allows for screening of company websites and follow-up of reported safety issues. Currently, social media is primarily used for safety reporting, though opportunities exist to leverage it for data retrieval, analysis, and risk communication. Challenges include validating self-reported social media safety data and ensuring data privacy. Future areas of impact could include establishing social media as an additional reporting channel to increase patient reporting and connect with consumers.
Unleashing the Potential of Social Media in Drug Safety Exploring the Increas...Covance
Pharmacovigilance has grown more complex over the past decade with higher data volumes, changing regulations, rise of social media, and innovative digital advances. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
The document discusses medical device bans by the FDA. It provides information on the reasons for bans, the process the FDA follows to ban devices, examples of banned devices, and types of bans. The FDA has the authority to ban devices that pose an unreasonable risk of injury. For a proposed ban, the FDA publishes its intent in the Federal Register and collects public comments. A final ban is issued after considering comments and affirms the agency's decision to prohibit future sales of a specific device.
Determining if Your Product is a Medical DeviceEMMAIntl
It may seem straightforward to determine if a product is a medical device or not but there is a surprising amount of gray-area in the field. The term “medical device” covers a simple tongue depressor to an implanted pacemaker and everything in between. A simple wooden stick is one product-development decision away from either being a popsicle stick, or a tongue depressor that crosses into a strict world of regulatory requirements...
The document summarizes the process by which the FDA approves new drugs for use and regulates drugs post-approval. It discusses how drugs are tested in clinical trials through an investigational new drug application and new drug application. It then outlines the FDA's role in reviewing applications and ensuring safety and effectiveness. Finally, it describes the FDA's ongoing role in regulating approved drugs, including product quality, labeling, adverse event reporting, and risk management. The House passed legislation that would reauthorize FDA drug user fee programs and make changes to the drug approval process.
This document discusses the FDA's regulation of digital health technologies under the 21st Century Cures Act. It provides an overview of the FDA's concept of digital health and criteria for different digital health technologies. It then summarizes key sections of the 21st Century Cures Act related to medical devices, including provisions that clarify the regulation of certain low-risk software. The document concludes by discussing the FDA's implementation of these policies, including guidance documents and a Digital Health Innovation Action Plan.
Request for Comments on Risk-Based Regulatory Framework for Health ITPatton Boggs LLP
The document summarizes a request from an interagency working group composed of the FDA, ONC, and FCC seeking public comments on developing a risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication. Specifically, the agencies are seeking comments on what types of health IT should be regulated, what risks health IT poses to patient safety and how to address them through a risk-based approach, and whether there are any current areas of regulatory overlap between the agencies. Comments may be submitted until August 31, 2013.
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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.
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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...
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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...
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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...
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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...
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTblessyjannu21
Prepared by Prof. BLESSY THOMAS, VICE PRINCIPAL, FNCON, SPN.
Emphysema is a disease condition of respiratory system.
Emphysema is an abnormal permanent enlargement of the air spaces distal to terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
Emphysema of lung is defined as hyper inflation of the lung ais spaces due to obstruction of non respiratory bronchioles as due to loss of elasticity of alveoli.
It is a type of chronic obstructive
pulmonary disease.
It is a progressive disease of lungs.
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
This particular slides consist of- what is hypotension,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 the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdfSachin Sharma
Here are some key objectives of communication with children:
Build Trust and Security:
Establish a safe and supportive environment where children feel comfortable expressing themselves.
Encourage Expression:
Enable children to articulate their thoughts, feelings, and experiences.
Promote Emotional Understanding:
Help children identify and understand their own emotions and the emotions of others.
Enhance Listening Skills:
Develop children’s ability to listen attentively and respond appropriately.
Foster Positive Relationships:
Strengthen the bond between children and caregivers, peers, and other adults.
Support Learning and Development:
Aid cognitive and language development through engaging and meaningful conversations.
Teach Social Skills:
Encourage polite, respectful, and empathetic interactions with others.
Resolve Conflicts:
Provide tools and guidance for children to handle disagreements constructively.
Encourage Independence:
Support children in making decisions and solving problems on their own.
Provide Reassurance and Comfort:
Offer comfort and understanding during times of distress or uncertainty.
Reinforce Positive Behavior:
Acknowledge and encourage positive actions and behaviors.
Guide and Educate:
Offer clear instructions and explanations to help children understand expectations and learn new concepts.
By focusing on these objectives, communication with children can be both effective and nurturing, supporting their overall growth and well-being.
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.
English Drug and Alcohol Commissioners June 2024.pptxMatSouthwell1
Presentation made by Mat Southwell to the Harm Reduction Working Group of the English Drug and Alcohol Commissioners. Discuss stimulants, OAMT, NSP coverage and community-led approach to DCRs. Focussing on active drug user perspectives and interests
At Malayali Kerala Spa Ajman, Full Service includes individualized care for every client. We specifically design each massage session for the individual needs of the client. Our therapists are always willing to adjust the treatments based on the client's instruction and feedback. This guarantees that every client receives the treatment they expect.
By offering a variety of massage services, our Ajman Spa Massage Center can tackle physical, mental, and emotional illnesses. In addition, efficient identification of specific health conditions and designing treatment plans accordingly can significantly enhance the quality of massaging.
At Malayali Kerala Spa Ajman, we firmly believe that everyone should have the option to experience top-quality massage services regularly. To achieve that goal we offer cheap massage services in Ajman.
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VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVedanta A
Air Ambulance Services In Rewa works in close coordination with ground-based emergency services, including local Emergency Medical Services, fire departments, and law enforcement agencies.
More@: https://tinyurl.com/2shrryhx
More@: https://tinyurl.com/5n8h3wp8
Sectional dentures for microstomia patients.pptxSatvikaPrasad
Microstomia, characterized by an abnormally small oral aperture, presents significant challenges in prosthodontic treatment, including limited access for examination, difficulties in impression making, and challenges with prosthesis insertion and removal. To manage these issues, customized impression techniques using sectional trays and elastomeric materials are employed. Prostheses may be designed in segments or with flexible materials to facilitate handling. Minimally invasive procedures and the use of digital technologies can enhance patient comfort. Education and training for patients on prosthesis care and maintenance are crucial for compliance. Regular follow-up and a multidisciplinary approach, involving collaboration with other specialists, ensure comprehensive care and improved quality of life for microstomia patients.
How the FDA Regulates the Advertising of Medical Devices
1. How the FDA Regulates the Advertising of
Medical Devices
By: Nikita Angane
FDA regulates the labeling and advertising of all pharmaceutical products; however, it regulates
the labeling of all medical devices and the advertising of only restricted devices.
Currently, only two types of class I & class II devices fall under the restricted devices category.
One is hearing aids and the other is Analyte Specific Reagents (ASRs). FDA may designate the
restricted device category for devices that are approved via the PMA route. Thus, most of the
class III devices are restricted, while no class I or class II devices are restricted except for the
hearing aids and ASRs.i
FDA, however, does have the authority to regulate the advertising of the non-restricted devices
related to its intended use. FDA issued several draft guidance documents in the past but has not
made any of them a final rule until now. The said draft guidance documents are:
1. Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and
Benefit Information for Prescription Drugs and Medical Devicesii
2. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation
About Prescription Drugs and Medical Devices iii
3. Presenting Risk Information in Prescription Drug and Medical Device Promotioniv
The first guidance is about how to communicate the risk information about the device/drug on
media sites that have character space limitations such as twitter, which has a limit of about 280
characters.
The second guidance document applies to information published by third parties on the social
media/internet regardless of that information being presented on the company’s own internet
platforms or third-party platforms.
The third guidance document describes how the FDA evaluates the promotional pieces of
prescription drugs and medical devices for the disclosure of the risk information to ensure that
the benefits and the risks are accurate and not misleading.
The recommendations in these guidance documents apply to the promotional materials directed
to the consumers, as well as healthcare professionals. However, these draft guidance documents
have not become a final rule.
2. Page 2 of 2
i Hyman, Phelps & McNamara (2014) What Legal Authority Does FDA Have to Regulate Medical Device Promotion
on Internet Social Media Platforms? Retrieved on 07/24/2019 from http://www.fdalawblog.net/2014/09/what-
legal-authority-does-fda-have-to-regulate-medical-device-promotion-on-internet-social-media-pla/
ii FDA (June 2014) Guidancefor Industry Internet/Social Media Platforms with Character SpaceLimitations —
Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices retrieved on 07/24/2019
fromhttps://www.fda.gov/media/88551/download
iii FDA (June 2014) Guidancefor Industry Internet/Social Media Platforms:Correcting Independent Third-Party
Misinformation AboutPrescription Drugs and Medical Devices retrieved on 07/24/2019 from
https://www.fda.gov/media/88545/download
iv FDA (May 2009) Guidancefor Industry Presenting Risk Information in Prescription Drugand Medical Device
Promotion retrieved on 07/24/2019 from https://www.fda.gov/media/76269/download