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FDA Notes Deficiencies with Neos ADHD Drug Review

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FDA tells Neos Therapeutics that it has identified deficiencies that preclude discussion of labeling and postmarketing requirement...

FDA Requests More Info on Zogenix Phase 3 Trial

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FDA requests additional information from Zogenix about the companys proposed Phase 3 program for ZX008, indicated for treating Dra...

Is FDA Backing Down on 1st Amendment Lawsuit?

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In a sign that it may be backing down from its position against truthful and non-misleading off-label promotion, FDA quietly remov...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Gentell and St. Jude Medical.

FDA Guidance on Device Manufacturing Site Changes

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FDA posts a draft guidance on Manufacturing Site Change Supplements: Content and Submission that explains the agencys current thin...

Womens Health Initiatives Meeting for Nursing Prof/Students

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Federal Register Notice: FDA plans a meeting 11/8 on Office of Womens Health Update on Strategic Priorities and Initiatives of int...

Violations Noted in Cipla Inspection

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Indias Economic Times newspaper says that FDA inspectors found several violations in an inspection at Ciplas Indore manufacturing ...

Researchers Question FDA Cancer Approvals with Surrogate Endpoints

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Two researchers writing in JAMA Internal Medicine say FDA since 2008 has been approving a higher percentage than in the past of ca...

Quality System Violations at St. Jude Medical

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FDAs Atlanta District Office warns St. Jude Medical about Quality System violations at its CardioMEMS unit.

Federal Circuit Denies En Banc Hearing on Biosimilars

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The Federal Circuit Court of Appeals denies Amgen and Sandoz petitions for rehearing and rehearing en banc of their case against S...