As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27).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 ...
Recent Updates
- 250+ Health Care Entities Targeted by HHS, DOJ Over Gender-Affirming Care for Minors
- Exclusion Authority (It’s Not Just the HHS-OIG Anymore …)
- The Sixth Circuit Revives the Medicare Waiver of Liability for Overpayments and Appeals
- Federal Court Holds Idaho’s Near-Total Abortion Ban Unconstitutional for Lack of Health Exception
- HRSA Announces Revised 340B Rebate Model Pilot Program for 2027