Introduction
Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar. If you are interested in Beluga caviar, would you think you had adequate opportunity to comment? Would you care if FDA argued that Beluga caviar was high in cholesterol so the two documents were related?
Blog Editors
Recent Updates
- Patent Infringement Lawsuit Alleges "Piracy" of AI-Driven Medical Technology
- DOJ Civil Division Accelerates Review of FCA Whistleblower Complaints Involving Federally Funded, State-Administered Benefits Programs
- FDA Warns Against “Over-Reliance” on AI Pharmaceutical Manufacturing . . . But How Much Reliance Is Too Much?
- Five Federal Cases Health Care and Life Sciences GCs Should Continue to Watch in 2026
- CMS Announces Nationwide Moratoria on New Medicare Enrollment for Hospices, Home Health Agencies