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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...

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...

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...

NECC Targeted in Grand Jury Probe: Newspaper

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A Boston newspaper reports that New England Compounding Center is the target of a federal grand jury investigation into its role a...

Info on IDE Reports Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on investigational device exemptions reports and records...