As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27).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
- CMS Tells States “No More” Medicaid Section 1115 Matching Funds for Designated State Health Programs (DSHP) and Designated State Investment Programs (DSIP)
- Podcast: Executive Actions Impact Federally Funded Research - What Institutions Should Do Now – Diagnosing Health Care
- A Closer Look at Proposed Changes to Medicare Advantage in the “No UPCODE Act”
- Green Commercial Leases
- Podcast: Criminal Health Care Fraud Enforcement - Projections for 2025 and Beyond – Diagnosing Health Care