Federal Register notice: FDA makes available a draft guidance entitled Bacillus Calmette-Gurin-Unresponsive Nonmuscle Invasive Bladder Cancer: Develop...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Four stakeholders give FDA general and specific recommendations on a draft guidance on bioresearch monitoring inspection processes and practices.
FDA publishes a guidance on optimizing dosage for oncologic drug and biologic therapies.
FDA approves an Amneal Pharmaceuticals NDA for Crexont (carbidopa and levodopa) extended-release capsules for treating Parkinsons disease.
Federal Register notice: FDA determines that Bayers Cipro (ciprofloxacin HCl) tablet, equivalent to 100 mg base, was withdrawn from sale due to safety...
