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GPhA Raises Concerns About Biologic Reference Exclusivity

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The Generic Pharmaceutical Association calls on FDA to make substantive changes to a draft guidance on biologic reference product ...

Draft Guidance on Federal Drug Tracing Efforts

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FDA issues a draft guidance to help industry and states understand the effects of the 2013 Drug Quality and Security Act requireme...

South Koreas Infopia Has QS Issues

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FDA warns South Koreas Infopia about Quality System violations in its manufacturing of several glucose and lipid devices.

New FDA Action Plans for Commodity-based Reg. Programs

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FDA commissioner Margaret Hamburg announces a new agency-wide collaborative, detailed regulatory program re-alignment to align our...

QS Violations Found at Ambco Electronics

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FDAs Los Angeles District Office warns Ambco Electronics about Quality System violations in its manufacturing of audiometers.

Teleflex Recalls Hudson Breathing Circuits

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FDA says Teleflex Medical is recalling Hudson RCI pediatric anesthesia breathing circuits.

FDA Draft Guide on Reducing OTC Acetaminophen Errors

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FDA posts a draft guidance on Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen that provides recommendatio...

Tobacco Center Seeks Tours Program Participants

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Federal Register Notice: FDAs Center for Tobacco Products Office of Science is seeking participants for its Laboratory Sites Tours...

Guidance on Breast Cancer Neoadjuvant Treatment Trials

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Federal Register Notice: FDA releases a guidance:Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage ...

FDA Advisory Panel To Review Watchman Device Again

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FDAs Circulatory System Devices Panel of the Medical Devices Advisory Committee reviews new data on a Boston Scientific PMA for th...