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CDRH Draft Guidance on 510(k) Transfers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CDRH posts a draft guidance on Transfer of a Premarket Notification (510(k) Clearance Questions and Answers.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

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.

FDA 510(k) Cleared with CLIA Waiver for Quidel Strep Test

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FDA issues 510(k) clearance and a Clinical Laboratory Improvement Amendments waiver for Quidel Corp.s Sofia Strep A+ Fluorescent I...

FDA Increasing Inspection Staff in China

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FDA says it is increasing the number of drug and food inspectors posted in China.

Aptiom Print Ad Overstates Efficacy: OPDP

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CDERs Office of Prescription Drug Promotion says that a Sunovion DTC print ad for Aptiom misleadingly overstates the products effi...

Industry Using Political Clout to Block Biosimilars: Public Citizen

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Public Citizen says the biologics industry has used its political power to delay marketing of generic biologics.

FDA Sends Collection of Info on Fast-Track Drugs to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on fast track drug development programs to...