On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and examples for firms who choose to address misinformation about or related to their approved or cleared drug or device.[1] This guidance revises and replaces FDA’s 2014 draft guidance titled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.” Social media users from 2014 will appreciate how different the world looks today and why—even though it took FDA ten years—this revision is a welcomed shift making it more straightforward for firms to respond to misinformation.
More Posts
LDT Final Rule Series: Part 2 – Response to the Rule
FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company
OIG Issues Favorable Advisory Opinion Regarding Patient Assistance Funds
LDT Final Rule Series: Part 1 – Rule Overview
FDA Warning Letter Regulates “Research Only” Labels
Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent
Oregon Prescription Drug Price Transparency Act in Limbo
FDA’s Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI®
OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial
Subscribe: Subscribe via RSS