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...
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Four stakeholders give FDA general and specific recommendations on a draft guidance on bioresearch monitoring inspection processes and practices.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Federal Register notice: FDA determines that Bayers Cipro (ciprofloxacin HCl) tablet, equivalent to 100 mg base, was withdrawn from sale due to safety...
Federal Register notice: FDA announces its fiscal year 2025 CDER Office of Pharmaceutical Quality Experiential Learning Site Visit Program.
