As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27).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 ...
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Recent Updates
- Federal Embryo Adoption Program Raises Potential Legal Questions for Reproductive Health
- Vermont’s H. 583 Restricts Private Equity and Hedge Funds with Ownership and Controlling Interests from Interfering with Clinical Judgment of Health Care Providers
- DOJ’s Second National Health Care Fraud Takedown of the Second Trump Administration Heavily Targets Medicaid Fraud
- FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements
- OIG Advisory Opinion 26-14 Offers Another Favorable Path for Patient Access Through Sponsored Testing