FDA releases a form FDA-483 with five observations from an inspection at the Cipla drug manufacturing facility in Goa, India.
FDA concurs with six recommendations made by the HHS Inspector General to improve the EUA process for tests in a future pandemic.
FDA approves Fennec Pharmaceuticals Pedmark to treat cisplatin-associated ototoxicity in pediatric patients.
Federal Register notice: FDA announces an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (n...
FDA approves a Guerbet NDA for Elucirem (gadopiclenol), a new macrocyclic gadolinium-based contrast agent for use in contrast-enhanced magnetic resona...
FDA issues contract manufacturer Catalent a 12-item Form FDA-483 over GMP concerns found during a recent inspection at the firms Bloomington, IN facil...
FDA clears a Medtronic 510(k) for its LINQ II Insertable Cardiac Monitor system for expanded use in pediatric patients over the age of two years who h...
FDA lifts a 12/2021-ordered clinical hold on a Merck IND to permit a new Phase 3 clinical program with once-daily islatravir for treating people with ...
