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Issues Found in GSK Aiken Inspection

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FDA releases an FDA-483 listing four observations from an inspection at GlaxoSmithKlines Aiken, SC, consumer healthcare facility.

Some Drug Price Hikes Related to FDA Safety

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Bloomberg Business says that an FDA effort to bring old unapproved drugs under modern regulation can lead to much higher prices fo...

FDA Safety Review Clears Zambons Monurol

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An FDA drug safety review of Zambons Monurol (fosfomycin) finds no new safety signals related to either parenteral or oral formula...

FDA Approves Alkermes Aristada for Schizophrenia

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FDA approves an Alkermes NDA for Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophreni...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites International Medical Development and MPH Nutrition.

Guide on Electronic Common Technical Document

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Federal Register Notice: FDA is making available an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Versi...

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...

Firm Selling Unapproved Gertie Marx Needles

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FDAs Denver District Office warns International Medical Development Corp. that it is manufacturing adulterated and misbranded Gert...

FDA Denies Otsuka Aristada Delay Petition

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FDA denies an Otsuka petition asking that approval for Alkermes Aristada be delayed or rejected.