- Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; Reopening of the Comment Period
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Reopening of the Comment Period
In November 2009, FDA held a Part 15 public hearing to gather comments and questions from our stakeholders (e.g., industry, health care professionals, consumers, patient groups, Internet vendors, advertising agencies, and other interested parties) on how FDA can best provide guidance on the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools.
The public hearing was instrumental in providing an opportunity for our stakeholders to comment. In addition to the 77 live presentations, we received 72 comments to the docket—a major collaborative effort by both the Agency and our stakeholders.
OPDP carefully considered input received both from outside and within the Agency and has since released four draft guidances that address various topics related to the public hearing. We look forward to receiving stakeholder feedback in the near future on the two draft guidances that were released on June 17, 2014, and to continuing our work in this ever-evolving landscape
Via Pharma Guy
This is unusual. Many of the major players -- PhRMA, WLF, BIO, etc. -- have already submitted comments. See my summary of comments re: character-limited social media platforms (here) and "Correcting Misinformation: Eliminate the "Influence Prong," Says Pharma Industry"