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FDA Approves Mylans Generic Atacand HCT

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FDA approves a Mylan Pharmaceuticals ANDA for candesartan cilexetil and hydrochlorothiazide tablets, a generic copy of AstraZeneca...

FDA Must Meet Internal Timelines: Ex-Inspector

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Former FDA inspector Patrick Stone says the agency should adhere to internal timelines for completing inspections and issuing Warn...

FDA Considers New Surrogate Endpoint for Kidney Disease Trials

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FDA considers new surrogate endpoints for clinical trials in chronic kidney disease patients based on a special scientific worksho...

FDA Accused of Violating FOIA on Animal Antibiotics

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The Government Accountability Project sues FDA over its refusal to provide animal antibiotic data in response to a Freedom of Info...

Bunnell Recalls Ventilator Patient Circuits

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Bunnell Inc. recalls its Life Pulse High-Frequency Ventilator Patient Circuits.

FDA Submits Info on Postmarket Reporting to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on applications f...

FDA Sends Info on Graphic Cigarette Labels

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Federal Register Notice; FDA submits a reinstatement collection on graphic cigarette labels to the Office of Management and Budget...

Meeting on Renewing Animal Drug User Fee Act

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Federal Register Notice: FDA plans a meeting 12/18 on the reauthorization of the Animal Drug User Fee Act.

R&D Rate of Return Still Falling

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A Deloitte analysis says that the internal rate of return for research and development in 12 leading drug companies fell for the s...

Appeals Court Backs Off-label Drug Promotions

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A federal appeals court ruling throws a wrench in FDAs use of off-label promotions as evidence of a pharmaceutical manufacturer's ...