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New from FDA: Transparency for Regulated Industry

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FDA principal deputy commission Joshua Sharfstein says his transparency task force is adding a new component: Transparency for Reg...

DoJ Pushing Drug Industry Foreign Bribes

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Assistant attorney general Lanny Breuer says the federal government is aggressively pursuing many Foreign Corrupt Practices Act in...

FDA Reportedly Studying Anti-epileptic Equivalence

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Attorney Kurt Karst says that a 2010 report to Congress should help resolve questions about the bioequivalence of branded and gene...

FDA Extends Review of IV Acetaminophen

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FDA extends by three months its review of a Cadence Pharmaceuticals NDA for intravenous (IV) acetaminophen.

Torgerson Debarred

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Federal Register Notice: FDA issues an order debarring Michelle Lynn Torgerson from providing services in any capacity to a person...

Public Docket on LASIK Info Reopened

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Federal Register Notice: FDA reopens the public docket to receive information on LASIK devices.

FDA Clears Platelet PGD Test System

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FDA clears Verax Biomedicals pooled platelet test system.

Social Media Hearing Tackles Adverse Event Reporting

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The second day of FDAs Internet Social Media hearing listens to stakeholders address how best to capture adverse event information...

Contaminants Possibly in Genzyme Products

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FDA notifies healthcare professionals about the potential for foreign particle contamination of several Genzyme products.

FDA OKs Drug for Heavy Menstruation

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FDA approves a Xanodyne Pharmaceuticals NDA for Lysteda tablets (tranexamic acid), a non-hormonal product for treating heavy menst...