Federal Register notice: FDA determines that Indiviors Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effective...
FDA publishes an immediately-in-effect guidance on developing drugs and biologics to prevent or treat some Covid-19.
Federal Register notice: FDA makes available a draft guidance entitled Translation of GLP Study Reports: Questions and Answers.
FDA declines to ban music in all DTC ads during the presentation of risk information.
FDA clears a Masimo 510(k) for Masimo W1 medical watch for providing continuous real-time oxygen saturation and pulse rate for over-the-counter and pr...
In a likely attempt to rebut a critical BMJ investigation, FDA and CDC officials explain, defend, and praise the Vaccine Adverse Event Reporting Syste...
A brief filed by the U.S. Solicitor General on behalf of FDA calls on the Supreme Court to hear the agencys appeal of a 5th Circuit Court of Appeals d...
FDA warns Dr. Melanie Hoppers/Physicians Quality Care in Jackson, TN, about violations in two clinical investigations at her study site.
