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The 5th Circuit Court of Appeals overrules a Texas federal court and says a suit by three doctors against FDA and HHS and their to...[ Price : $8.95]
FDA clears a Techsomed 510(k) for its VisAble.IO software intended to assist physicians in planning liver ablation procedures and ...[ Price : $8.95]
FDA warns Medley, FL-based Lex, Inc., about repeat CGMP violations in its production of finished drugs as a contract facility.[ Price : $8.95]
Federal Register notice: FDA publishes a draft guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobact...[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA.[ Price : $8.95]
Federal Register notice: FDA withdraws 35 no-longer-marketed NDAs from multiple applicants.[ Price : $8.95]
Federal Register notice: FDA announces a public meeting to discuss proposed recommendations for the reauthorization of the Over-th...[ Price : $8.95]
FDA warns South Koreas Green Pharmaceutical Co. in Jincheon about CGMP violations in its manufacturing of over-the-counter drugs.