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9th Circuit Denies Gilead FCA Case Rehearing

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The 9th Circuit Court of Appeals declines to rehear a whistleblower case involving three Gilead HIV drugs.

Gottlieb Outlines Changes to Expanded Access Program

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FDA commissioner Scott Gottlieb says the agency is making changes to make it easier for patients to gain access to experimental th...

Joint FDA Panel to Review Braeburn Pharmaceuticals Drug

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Federal Register notice: An FDA advisory committee reviews a Braeburn Pharmaceuticals NDA for buprenorphine subcutaneous injection...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Dasan E&T Co. and Diasol East.

FDA Advisory Panel to Review Diabetes Drug

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Federal Register notice: FDA announces a 10/18 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Novo Nor...

Joint Panel to Mull Opioid Dependence NDA

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Federal Register notice: FDA joint advisory committee meeting reviews Indivior Pharmaceuticals NDA for buprenorphine subcutaneous ...

Comments Sought on REMS Standards Initiative

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Federal Register notice: FDA seeks public input on the design of its REMS Platform Standards Initiative, as well as methods and be...

Draft Guide on Diagnostic Ultrasound Systems and Transducers

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FDA makes available a draft guidance on Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.

Two FDA Guidances on Advancing Complex Drug Generics

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FDA releases two guidances as part of its initiative to make it easier to introduce generic copies of complex drugs.

FDA Guide on Requesting Rationales of Significant Decisions

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FDA posts a guidance on Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A.