FDA’s Post

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.

Updated Draft Guidance from the FDA Take a Look 👀✍️ #FDA #Guidance #MedicalDevices #PrescriptionDrugs #Standards #Regulations #IndustryUpdates #MicroBioConsulting

🚨 New Guidance Alert 🚨 The FDA has released a draft guidance document to address misinformation about medical devices and prescription drugs.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 This draft guidance aims to ensure that the public receives accurate, up-to-date, science-based information to make informed decisions about medical products. This revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued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®

The new draft guidance from the FDA on addressing medical product misinformation introduces several key changes and updates compared to the 2014 draft guidance.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.

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

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

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

Today, the FDA revealed a new draft guidance for industry, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers," providing valuable strategies for companies to proactively address misinformation associated with their approved medical products. This updated guidance supersedes the previous version released in June 2014, offering fresh perspectives on combating misinformation in the healthcare industry. #FDA #MedicalDevices #PrescriptionDrugs #DraftGuidance #HealthcareIndustry

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 has issued a guidance document that, when finalized, will describe the FDA’s current thinking on questions firms may have when addressing misinformation about or related to their approved and cleared medical products. This guidance revises and replaces the draft guidance entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” that was issued in June 2014. You can review the guidance here: https://lnkd.in/g2cB2gQA