On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
FDA Issues Long-Awaited Draft Guidances on Internet and Social Media Advertising
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; and
- Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.
The first guidance offers recommendations on how prescription drug and device companies can correct inaccurate information about their products posted by third parties on internet and social media sites. The second guidance addresses how these same companies can discuss their products on internet platforms with space restrictions, including social media sites and paid search links on Google and Yahoo. Comments for both guidances are due within 90 days.
Today’s draft guidances address two issues of particular interest to Hogan Lovells clients – providing links to risk information within microblogs and correcting misinformation about products from third parties. Thus, we urge everyone to read these carefully.
Today’s draft guidances add to the social media draft guidance that the agency promulgated in January: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, see our HL Regulatory blog post here. FDA has also indicated that its guidance agenda for 2014 includes guidance regarding the use of links in advertising and promotional labeling.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017