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Workshop on Devices to Treat Metabolic Diseases

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Federal Register Notice: FDA plans a public workshop 10/17 on changing regulatory and reimbursement paradigms for medical devices ...

FDA Complete Response Letter on Delcath NDA

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FDA issues Delcath Systems a complete response letter for an NDA for its Melblez Kit (melphalan) for injection for use with the De...

Ge Pharma Recalls Stimulant-containing Creafuse

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Ge Pharma recalls Creafuse Powder Grape (Lot# GE4568) and Creafuse Powder Fruit Punch (Lot #GE4570) because they contain an undecl...

CDER Adds Lexiscan to Safety Watch List

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CDER says it has identified a potential safety issue with Astellas Lexiscan (regadenoson) an increased risk of myocardial infarct...

Fast Track Status Given to Synta Lung Cancer Drug

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FDA grants Synta Pharmaceuticals a fast track designation for ganetespib, a heat shock protein 90 (Hsp90) inhibitor drug candidate...

Bioanalytical Method Validation Guidance

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FDA issues a draft guidance on developing bioanalytical method validation information for human and animal drugs.

BMS Yervoy Misses Phase 3 Endpoint

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Bristol-Myers Squibb says a Phase 3 trial of its Yervoy in treating advanced prostate cancer failed to meet its primary endpoint o...

United Therapeutics Re-files NDA for Treprostinil Diolamine

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United Therapeutics resubmits an NDA for treprostinil diolamine extended release tablets for treating pulmonary arterial hypertens...

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...