When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA's position, Twitter was not going to be a medium that ...
As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27). FDA does not often reopen the door to comment after the required notice-and-comment period has closed, and the fact that FDA has chosen to do so for these draft guidances is significant. In all three cases, FDA received communications from stakeholders requesting additional time to digest the ...
Blog Editors
Recent Updates
- DEA Issues Third Extension to Public Health Emergency Telemedicine Prescribing Flexibilities, Through 2025
- CMS Issuing First Risk Adjustment Data Validation Audit Notices for PY2018 Since the RADV Final Rule
- Just Released: Telemental Health Laws – Download Our Complimentary Survey and App
- HISAA: New Legislation Would Bring Cybersecurity Requirements for HIPAA Covered Entities and Business Associates
- Post-Hurricane Flexibilities Offered by the U.S. Department of Health and Human Services Through the Centers for Medicare & Medicaid Services