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Info Corrected on Preoperative Skin Prep Products Hearing

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Federal Register Notice: FDA corrects a 11/21 notice on antiseptic patient preoperative skin preparation products.

Participants Sought to Select Device GMP Panelists

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Federal Register Notice: FDA seeks participants to select nonvoting industry representatives to serve on CDRHs Device Good Manufac...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Avis Dairy, Casmed, New Star Lasers, Shanghai Ruike Sports, Shanghai Huhui Daily...

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...

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...