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FDA Accepts Mylan ANDA for Generic Copaxone

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FDA has accepted for filing a Mylan ANDA for a three-times-per-week glatiramer acetate injection 40 mg/mL, a generic of Tevas MS d...

Dont Duplicate Testing that Follows FDA Methods: BIO

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BIO and Novartis voice disagreement with FDAs proposed use of Phonetic and Orthographic Computer Analysis scores in determining th...

Cardiovascular Trials Need Better Generalizability: Researchers

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University of Toronto researchers analyzing a cardiovascular trial registry find that in clinical trials that included heart attac...

Comments Sought on Tobacco Product Applications

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Federal Register Notice: FDA releases for comment 10 tobacco product applications from Swedish Match North America.

DePuy Class 1 Recall for Synthes Craniomaxillofacial Distraction System

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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 ...