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Sharfstein Says REMS Allows Drugs to Remain on Market

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FDA principal deputy commissioner Joshua Sharfstein says that without the ability to impose a REMS, FDA probably would have had to...

FDA Wants More Tapentadol Data, No New Trials

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FDA says it wants more data on a new extended-release formulation of Johnson & Johnsons tapendatol

FDA Agrees to Estybon SPA

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FDA says it has reached agreement with Onconova Therapeutics on an SPA for a Phase 3 trial of Estybon in patients with myeldosplas...

Synthes, Norian Plead Guilty to Clinical Trials Charges

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Synthes and its Norian subsidiary agree to plead guilty to federal charges stemming from the companies clinical trials of a Norian...

FDA PDUFA Report Shows Improvements

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FDA says it is making significant progress with its FY 2009 drug user fee performance after falling behind in FY 2008 due to addit...

FDA Approves Mylan's Generic Wellbutrin

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FDA approves a Mylan Pharmaceuticals ANDA for a generic copy of GlaxoSmithKline's antidepressant Wellbutrin XL.

FDA Releases Enforcement Plan for Tobacco Advertising

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Federal Register Notice: FDA releases an enforcement action plan for promotion and advertising restrictions on menthol and other c...

CDRH Posts Web Site for Possible Guidances

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Federal Register Notice: FDA announces a Web site location where it will post a list of guidance documents CDRH is considering for...

Comments Sought on FDA Strategic Priorities

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Federal Register Notice: FDA seeks comments on its Strategic Priorities FY 2011-2015.

FDA To Take Action Against Unapproved Colchicine Products

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Federal Register Notice: FDA plans to take enforcement action against unapproved single-ingredient oral colchicine products and th...