FDA clears a Techsomed 510(k) for its VisAble.IO software intended to assist physicians in planning liver ablation procedures and confirming ablation ...
FDA warns Medley, FL-based Lex, Inc., about repeat CGMP violations in its production of finished drugs as a contract facility.
Federal Register notice: FDA publishes a draft guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex ...
Federal Register notice: FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA.
Federal Register notice: FDA withdraws 35 no-longer-marketed NDAs from multiple applicants.
Federal Register notice: FDA announces a public meeting to discuss proposed recommendations for the reauthorization of the Over-the-Counter Monograph ...
FDA warns South Koreas Green Pharmaceutical Co. in Jincheon about CGMP violations in its manufacturing of over-the-counter drugs.
FDA publishes an updated guidance on standards for the interoperable exchange of information for tracing certain drugs under the Drug Supply Chain Sec...
