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Pediatric Oncology Panel to Meet

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 12/15 to discuss developing pediatric cancer drugs and dos...

FDA Withdraws Product from OTC Monograph Consideration

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Federal Register Notice: FDA withdraws notice of eligibility for S. boulardii to be considered for the OTC monograph for antidiarr...

SPL Labeling Content Standard Guidance Out

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FDA issues the first revision of a 2005 guidance on using the SPL standard for labeling content.

Panel to Discuss sNDA for Crestor

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 12/15 to discuss Astra Zenecas sNDA ...

FDA Corrects FY 2010 PDUFA Fees

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Federal Register Notice: FDA corrects the errors in an 8/3 notice announcing the FY 2010 PDUFA fees.

Public Workshop on Arboviruses

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Federal Register Notice: FDA plans a public workshop 12/14-15: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue, and ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites 17 LASIK facilities.

TMJ Implants Loses on All Counts to FDA

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Embattled Colorado medical device maker TMJ Implants Inc. loses its final FDA battle in the U.S. Court of Appeals for Tenth Circui...

Republicans Draft Debarment Bill

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Rep. Joe Barton and other House Energy and Commerce Committee Republicans draft legislation to strengthen FDAs ability to quickly ...

DDMAC Cites Sanofi-Aventis Promo

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DDMAC cites a Sanofi-Aventis voucher tent card for Uroxatral, saying it is misleading and fails to present its indication despite ...