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Spectrum Pharma Petitions FDA to Block Fusilev Generics

[ Price : $8.95]

Spectrum Pharmaceuticals petitions FDA asking that it not approve any ANDAs that seek to carve-out Fusilevs orphan drug exclusivit...

Will FDA Raise Cybersecurity Goals in Device Submissions?

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A client alert from law firm Sheppard, Mullin, Richter & Hampton hints at increased FDA scrutiny for medical devices that lend the...

FDA Publishes List of Device Standards

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Federal Register Notice: FDA publishes a modified list of recognized standards that it recognizes for use in premarket reviews.

FDA Posts GSK Letters to MDs on Vaccine Label Fading

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FDA posts a Dear Healthcare Provider letter from GlaxoSmithKline informing physicians about the potential for fading over time on ...

FDA Clears AnthroTronix DANA App for Psych Testing

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FDA clears an AnthroTronix 510(k) for its computerized cognitive test battery DANA, which is intended to provide clinicians with a...

FDA OKs Clinical Trial in Ebola Patients

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FDA approves a Phase 2 clinical trial protocol from Chimerix to begin clinical trials of brincidofovir in Ebola patients.

FDA Approves Abuse-deterrent Claim on Pfizers Enbeda

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FDA approves new abuse deterrent labeling for Pfizers painkiller Embeda (morphine sulfate and naltrexone hydrochloride) extended-r...

Spectrum Wants Fusilev Approval Date, Exclusivity Extended

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Spectrum asks FDA to extend the approval date and orphan drug expiration date for its Fusilev to account for the delay in launch c...

Advisors Asked About Cosentyx Efficacy, Safety

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FDA medical reviewers tell the Dermatologic and Ophthalmic Drugs Advisory Committee that Novartis data show a favorable benefit-ri...

Comments Sought on Consumer Tobacco Panel

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Federal Register Notice: FDA seeks comments on establishing a probability-based panel of tobacco users.