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Guidance on Bioanalytical Method Validation

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Federal Register Notice: FDA releases a draft guidance: Bioanalytical Method Validation.

Bipartisan Drug Compounding Bill Introduced in House

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A bipartisan group of House lawmakers introduce a bill that would clarify FDAs authority over large-scale pharmacy drug compoundin...

FDA Clears NeoTract UroLift System

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FDA clears a de novo 510(k) for NeoTracts UroLift system, the first permanent implant to relieve low or blocked urine flow in men ...

Group Calls for Measured NSAID Use as Opioid Alternative

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The Alliance for Rational Use of NSAIDs reminds consumers of proper NSAID usage in case they use them as alternatives to opioid an...

Sanofi Withdrawing Lixisenatide NDA

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Sanofi says it is withdrawing its lixisenatide NDA until 2015 when complete ELIXA cardiovascular trial results are available.

Use Medical Device Preemption Standard for Drugs: Attorneys

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Reed Smith attorneys suggest that Congress could improve the prescription drug preemption situation by mandating a standard simila...

Communicate Considerations to IDE Sponsors: Letters

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St. Jude Medical and Covidien recommend that FDA communicate future and study design considerations to IDE sponsors outside of the...

Janssen Recalls 1 Risperdal Lot Over Mold Concerns

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Johnson & Johnson drug unit Janssen Pharmaceuticals recalls one lot of antipsychotic drug Rispedal Consta (risperidone) long-actin...

Gilead Sciences NDA for non-Hodgkins Lymphoma

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Gilead Sciences files an NDA for idelalisib, an investigational targeted oral inhibitor of PI3K delta for treating indolent non-Ho...

ODAC Recommends Accelerated Perjeta Approval

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FDAs Oncologic Drugs Advisory Committee recommends accelerated approval for Genentechs Perjeta for an indication for neoadjuvant t...