FDA says Teva recalled one lot of anagrelide capsules due to dissolution test failure.
Federal Register notice: FDA makes available a draft guidance entitled Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatme...
Federal Register notice: FDA makes available a draft guidance entitled Risk Management Plans to Mitigate the Potential for Drug Shortages.
Federal Register notice: FDA proposes new regulations that would amend the requirements on current good manufacturing practices and postmarketing safe...
Federal Register notice: FDA corrects a 5/11 notice entitled Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal.
FDA principal deputy commissioner Janet Woodcock and two other FDAers praise agency efforts to increase participation of women in clinical trials and ...
Three FDAers and a drug researcher give an overview of physiologically-based biopharmaceutics modeling.
ImmunityBio files a BLA for N-803, which it describes as a first-in-class IL-15 superagonist, plus Bacillus Calmette-Gurin (BCG) for treating BCG-unre...