Braun Medical recalls (Class 1) two lots of 0.9% sodium chloride for injection USP 1,000 mL due to the potential for particulate matter in the drug co...
FDA selects American College of Cardiology chief innovation officer Ami Bhatt to serve a four-year term as chair of the agencys recently created Digit...
Federal Register notice: FDA makes available a final guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for t...
Federal Register notice: FDA makes available a draft guidance entitled Bacillus Calmette-Gurin-Unresponsive Nonmuscle Invasive Bladder Cancer: Develop...
FDA lifts a clinical hold against 4D Molecular Therapeutics 4D-310 therapy being studied for treating Fabry disease cardiomyopathy.
Federal Register notice: FDA announces an 11/19 advisory committee meeting to discuss potential changes to the clozapine risk evaluation and mitigatio...
FDA releases the form FDA-483 with four observations from an inspection at the Ledgewood, NJ-based Imprimis NJOF outsourcing facility.
Four stakeholders give FDA general and specific recommendations on a draft guidance on bioresearch monitoring inspection processes and practices.
