Federal Register notice: FDA determines that Indiviors Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effective...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Federal Register notice: FDA makes available a draft guidance entitled Translation of GLP Study Reports: Questions and Answers.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...
FDA warns Dr. Melanie Hoppers/Physicians Quality Care in Jackson, TN, about violations in two clinical investigations at her study site.
FDA commissioner Robert Califf says there have been discussions about whether public funding should be used to support some key postmarketing evidence...
Due to concern about microbial contamination, Bayer recalls one lot of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles.
