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CNS Drugs Longer to Develop, Approve: Tufts Center

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A Tufts Center for the Study of Drug Development analysis shows that central nervous system drugs take longer to develop and appro...

FDA Finds Violations in 2 Medtronic Inspections

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FDA warns two Medtronic manufacturing facilities about Quality System violations in their production of cardiac medical devices.

Integrate Cybersecurity in Medical Device Reviews: OIG

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The HHS Inspector General outlines steps FDA could take to better integrate cybersecurity concerns into its medical device reviews...

Panel to Review Pain Drug

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Federal Register notice: FDA announces a 10/11 Anesthetic and Analgesic Drug Products Advisory Committee meeting.

Joint Advisory Panel to Review Irritable Bowel Drug

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Federal Register notice: FDA announces a 10/17 joint advisory committee meeting to review an irritable bowel syndrome drug.

CGMP Violations Found in Lernapharm Inspection

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FDA warns Canadas Lernapharm about CGMP violations in its production of finished drugs.

Comments on Draft Indications and Usage Labeling Guidance

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Four pharmaceutical stakeholders submit comments on an FDA draft guidance on writing the Indications and Usage section in product ...

Procedural Deficiency in Lupin Tarapur Inspection

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Indias Lupin says an FDA inspection at its Tarapur drug manufacturing facility closed with one observation the company considers t...

CGMP Violations at Chinas Longwood Medicine (Beijing)

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FDA warns Chinas Longwood Medicine (Beijing) about CGMP violations in its production of an unapproved new drug.

Guide on Drug Substance Postapproval Changes

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Federal Register notice: FDA makes available a draft guidance entitled Postapproval Changes to Drug Substances.