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Pilot Project for Drug REMS in SPL Format

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Federal Register Notice: FDA seeks participants in a pilot projfect for application holder of drugs with Risk Evaluation and Mitig...

Info on Generic Drug User Fees Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the generic drug user fee cover sheet to the Office o...

AdvaMed Seeks Clarification on UDI Compliance Exceptions

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Advanced Medical Technology Association says FDA should clarify that a three-year compliance date exception allowed under the Uniq...

FDA Approves McGuff ANDA for Generic Delalutin

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FDA approves a McGuff Pharmaceuticals ANDA for hydroxyprogesterone caproate injection USP, 250 mg/mL (1.25 g/5 mL vials), a generi...

BMS Settles SEC Charges Over China Misconduct

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Bristol-Myers Squibb agrees to settle charges that a joint venture in China made cash payments and provided other benefits to heal...

ANDA Approval Allowed After Draft Labeling Review: FDA

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FDA says it will speed up generic drug approvals by allowing marketing on the basis of submitted draft, rather than final printed ...

FDA Warning Letter to St. Jude Medical

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FDA issues St. Jude Medical a Warning Letter citing its Atlantia, GA manufacturing facility for GMP violations related to the manu...

Comments Sought on Xenotransplantation Guideline

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Federal Register Notice: FDA seeks comments on a proposed collection of information in the Public Health Service guideline on xeno...

Comments Sought on Abuse Potential of 10 Drug Substances

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Federal Register Notice: FDA requests comments on the abuse potential, etc. of 10 drug substances to prepare a response to the Wor...

FDA Alert on Bioprosthetic Aortic Valve Motion

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FDA says it has received recent reports about the reduced leaflet motion in some bioprosthetic aortic valves, including both trans...