Federal Register notice: FDA reopens the comment period on a draft guidance entitled ICH Q12: Implementation Considerations for FDA-Regulated Products...
Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for Quantitative Testing for the Develop...
FDA declines to grant emergency use authorization to Humanigens lenzilumab for treating newly-hospitalized Covid-19 patients.
FDA grants breakthrough device designation to Novocures TTFields system for use with two liver cancer drugs.
FDA and the Federal Trade Commission warn 10 companies that they are illegally marketing drugs to treat diabetes as dietary supplements.
Council for Responsible Nutrition CEO Steve Mister says Congress must regulate the cannabidiol market since FDA is unwilling to.
ICU Medical recalls one lot of Aminosyn II, 15% (amino acid injection) sulfite-free intravenous solution due to the presence of visible particulate ma...
Moderna says a Phase 2 trial shows a robust response to a third or booster shot of its Covid-19 mRNA vaccine.