Today, FDA issued an updated draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe FDA’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products.
Synterex’s Post
More Relevant Posts
-
On July 8th, The #FDA issued a new DRAFT #fdaguidance to replace a 2014 draft of Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers. This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. https://lnkd.in/e4gzBYT7
Addressing Misinformation About Medical Devices and Prescription Drugs
fda.gov
-
The FDA issued a draft guidance for industry, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers," which, when finalized, will describe FDA's current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/ cleared medical products. https://lnkd.in/ewetyxQX #regulatoryaffairs #regulatory #regulatorysubmission #cmc #dossier #regulatoryscience #regulation
Addressing Misinformation About Medical Devices and Prescription Drugs
fda.gov
-
As an attorney, I represent pharmaceutical, biologic and medical device companies in regulatory, commercial & FDA enforcement defense matters.
There is a legal aspect here as well: what liability do you have for correcting or not correcting? Can you be expected to Police the internet? What are your obligations. More in this in my posts to follow.
Today, FDA issued a draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe FDA’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products: https://lnkd.in/e4gzBYT7 This revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued in June 2014.
-
Today, FDA issued a draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe FDA’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products: https://lnkd.in/e4gzBYT7 This revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued in June 2014.
-
Purpose-driven healthcare leader | Cell & Gene Therapy | Radiopharmaceutical | Biotech & Pharmaceutical | Regulatory Compliance and Transformation
🚨 New Guidance Alert 🚨 The FDA has released a draft guidance document to address misinformation about medical devices and prescription drugs. This comprehensive document provides answers to common questions firms may have when voluntarily tackling misinformation related to their approved/cleared medical products. 📝 Key Highlights: ✒ Tailored Responsive Communications: Recommendations for internet-based communications that address misinformation. ✒ General Medical Product Communications: Existing avenues for firms to communicate accurate information under FDA Authorities. This draft guidance aims to ensure that the public receives accurate, up-to-date, science-based information to make informed decisions about medical products. This revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued in June 2014. 🔗 For more information, visit FDA Guidance Documents. #Healthcare #FDA #MedicalDevices #PrescriptionDrugs #Misinformation #PublicHealth #Guidance #Pharma #Drugs #RegulatoryAgency Compliance Architects®
Today, FDA issued a draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe FDA’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products: https://lnkd.in/e4gzBYT7 This revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued in June 2014.
-
Updated Draft Guidance from the FDA Take a Look 👀✍️ #FDA #Guidance #MedicalDevices #PrescriptionDrugs #Standards #Regulations #IndustryUpdates #MicroBioConsulting
Today, FDA issued a draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe FDA’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products: https://lnkd.in/e4gzBYT7 This revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued in June 2014.
-
Attorney-at-law | Business Advisor & Facilitator | Science Admirer | Generalist | Member to the Leadership Team | Regulatory Compliance | Company Secretary
The new draft guidance from the FDA on addressing medical product misinformation introduces several key changes and updates compared to the 2014 draft guidance. Here are the main new elements: 1. Firms can now use "tailored responsive communications" to address internet-based misinformation about their approved products. These communications are exempt from certain promotional labeling and advertising requirements if they follow FDA recommendations. 2. Addressing misinformation about unapproved uses won't be used as evidence of a new intended use if guidelines are followed. This provides more flexibility for companies to correct misinformation without regulatory consequences. 3. The guidance emphasizes the importance of ensuring the public has access to accurate, science-based information for informed decision-making about medical products. 4. The guidance highlights particular concern for misinformation about products treating serious diseases, recognizing the potential impact on public health. 5. While the 2014 guidance focused on internet and social media platforms, the new guidance appears to have a broader scope in terms of where misinformation might appear and be addressed It is a significant shift in approach, allowing manufacturers/distributors to more effectively combat misinformation while maintaining regulatory compliance. Hopefully this should improve public health outcomes by ensuring access to accurate product information in the world of digital age, which is quite vulnerable to half-truths.
Today, FDA issued a draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe FDA’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products: https://lnkd.in/e4gzBYT7 This revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued in June 2014.
-
FDA Issues Revised Draft Guidance on Addressing Misinformation About Prescription Drugs and Medical Devices Today, FDA issued a draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe the agency’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products. This revised draft guidance would apply only to approved/cleared medical products, which include medical devices for human use (including biological products), prescription human drugs (including biological products), and prescription animal drugs. This document revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued in June 2014. This revised guidance will help the public get the accurate, up-to-date, science-based information they need to inform their decisions about medical products to maintain and improve their health. #fda #prescription #misinformation #guidance #drugs #medicaldevices https://lnkd.in/ewetyxQX
Addressing Misinformation About Medical Devices and Prescription Drugs
fda.gov
-
At Zyfis Lifesciences, we are pleased to share this essential guidance document on addressing misinformation about medical devices and prescription drugs. Explore clear, evidence-based answers for the industry in this comprehensive PDF. #regulatory #medicaldevice #drugs #fda
-
The FDA announces a revised draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.” This update provides insights on how firms can voluntarily address misinformation about their approved/cleared medical products. Join the conversation and help shape the future of accurate medical information! 🔗 Find out more - Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers | FDA #USFDA #FDA #Healthcare #MedicalDevices #PrescriptionDrugs #Misinformation #Guidance #ema #cdsco
