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DePuy Class 1 Recall for Synthes Craniomaxillofacial Distraction System

[ Price : $8.95]

DePuy Synthes recalls certain lots of its Craniomaxillofacial Distraction System because the device may reverse direction and lose...

The Importance of Data Integrity and Audit Trails: Blog

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Software maker Accelrys describes the regulatory importance of data integrity and audit trails in the U.S. and EU.

FDA Priority Review for Amgen Heart Failure NDA

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FDA grants Amgen a priority review designation for its NDA for ivabradine for treating chronic heart failure.

FDA Wants cGMP Culture of Compliance: Attorney

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Attorney Shashank Upadhye says drug companies must create a cGMP culture of compliance based on employee training.

Federal Court Recognizes FDA Dilemma in Ordering Recall

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The Maryland federal district court acknowledges that FDA cant order generic makers of Hospiras sedation drug Precedex, subject to...

FDA Corrects Notice on Biosimilar User Fee Rates

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Federal Register Notice: FDA corrects a docket number in a Federal Register notice announcing the biosimilar use fee rates for FY ...

FDA Sets Tropic Disease Priority Review Rates

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Federal Register Notice: FDA announces the fee rates for using a tropical disease priority review voucher for fiscal year 2015.

FDA Corrects Notice on Outsourcing Facility Fees

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Federal Register Notice: FDA corrects a docket number in a Federal Register notice announcing the FY 2015 fees for human drug comp...

Info on Drug Compounding Facility Guidance 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 guidance on ...

Guidance on Generic Drug Development Correspondence with FDA

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Federal Register Notice: FDA releases a draft guidance: Controlled Correspondence Related to Generic Drug Development.