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PhRMA Concerned on REMS Training as Part of Continuing Education

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Pharmaceutical Research and Manufacturers of America says it is highly concerned about FDAs plans to focus on risk evaluation and ...

FDA Asks Herbalife to Pull Misleading Video

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FDA asks Herbalife to stop running a broadcast advertisement and YouTube video that mischaracterizes the agencys regulatory role w...

FDA Plans Conference on Drug-Induced Liver Injuries

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Federal Register Notice: FDA plans a public conference 3/18-19/15 on serious drug-induced livery injuries.

Info on Form FDA 3674 Sent to OMB

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

CDRH Draft Guidance on 510(k) Transfers

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CDRH posts a draft guidance on Transfer of a Premarket Notification (510(k) Clearance Questions and Answers.

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, to reopen on Monday, January 5, 2015.

UDI Account Requests for Life-supporting Implants

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CDRH says that in January it will begin accepting Global Unique Device Identification Database account requests from labelers of i...

Public Meeting on Breast Cancer Drug Development

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Federal Register Notice: FDA plans a public meeting 4/2 on patient-focused drug development for breast cancer.

Sen. Brown Urges FDA to Ban Powdered Caffeine

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Sen. Sherrod Brown (D-OH) calls on FDA to immediately ban the retail sales of powdered caffeine due to safety concerns.

Lundbeck Scraps Stroke Drug Development

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H. Lundbeck A/S discontinues developing its investigational ischemic stroke drug desmoteplase.