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Hospira Recalls One Vancomycin Lot

[ Price : $8.95]

Hospira recalls one lot of vancomycin hydrochloride for injection because the product may have experienced temperature excursions ...

SAM Medical Recalls Tourniquet Accessory Clip

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SAM Medical Products recalls clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniq...

OMB OKs Info on Classifying OTC Drugs as GRASE

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Federal Register Notice: The Office of Management and Budget approves a collection of information on additional criteria and proce...

Guidance on OTC Pediatric Liquids with Acetaminophen

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Federal Register Notice: FDA releases a draft guidance: Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.

FDA Science Board to Meet

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Federal Register Notice: The Science Board to FDA will meet 11/19-20 to discuss, among other topics, anesthetics and sedation drug...

Drug Umbrella Names Lead to Confusion: ISMP

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The Institute for Safe Medication Practices calls for regulatory changes to require that products given an umbrella name contain a...

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The Generic Pharmaceutical Association calls on FDA to make substantive changes to a draft guidance on biologic reference product ...

Draft Guidance on Federal Drug Tracing Efforts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FDA issues a draft guidance to help industry and states understand the effects of the 2013 Drug Quality and Security Act requireme...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...