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FDA Sets July Review Target for Astellas NDA

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FDA accepts for review an Astellas Pharma U.S. NDA for tacrolimus extended-release capsules for preventing organ rejection in adul...

Are Antibiotic Trial Requirements Too Tough?

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Observers of the antibiotic market question whether FDA is really changing its approval requirements for clinical trials that they...

QS Violations at Casmed International

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FDA warns Casmed International about Quality System violations in its manufacturing of medical devices.

CDERs Temple on Breakthrough Therapy Program

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CDER deputy director for clinical science Robert Temple explains the difference between the Centers newly acquired breakthrough th...

Guidance on INDs for PET Drugs

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Federal Register Notice: FDA releases a guidance, Investigational New Drug Applications for Positron Emission Tomography (PET) Dru...

Grace Period for Generic Drug Facility ID

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FDA says it is giving a two-week grace period for generic drug manufacturing facility self-identification required under the Gener...

Obama Urged to Retain Hamburg at FDA

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FDA commentator and Alliance for a Stronger FDA officer Steven Grossman urges President Obama to retain Margaret Hamburg as FDA co...

Rep. Introduces Innovation and Technologies Act

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Rep. Honda introduces legislation he says will increase healthcare innovation through use of marketplace incentives, challenge gra...

FDA Approves New Labeling for Sucampo

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FDA approves a Sucampo Pharmaceuticals supplemental NDA that removes pregnancy warnings and precautions related to Amitiza (lubipr...

Jazz Pharma Begins Trial in Leukemia Patients

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Jazz Pharmaceuticals begins a clinical trial involving asparaginase Erwinia chrysanthemi administered intravenously as an alternat...