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Mizuho Table Recall is Class 1

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FDA says that Mizuhos recall of its OSI modular table systems due to the potential for patient injuries is a Class 1 recall.

Woodcock on Building Quality In

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CDER director Janet Woodcock discusses her concept of building quality in cooperatively to the structure of drug clinical trials....

CBO Sees Generic Drug Legislation Savings

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The Congressional Budget Office estimates a reduction in federal budget deficits of nearly $5 billion over 10 years from a bill to...

Former CDRH Compliance Head Lands at Consulting Firm

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Recently retired CDRH Office of Compliance director Tim Ulatowski joins Becker & Associates Consulting in the firms Washington, DC...

FDA, NephroGenex Agree on Surrogate Endpoint

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FDA and NephroGenex reach agreement on the design of a new Phase 3 Subpart H (accelerated approval) program that evaluates Pyridor...

Number of Monoclonal Antibodies Increasing

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The Tufts Center for the Study of Drug Development says that the number of monoclonal antibodies in clinical study has been steadi...

Should FDA Run Health IT?

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An Institute of Medicine report says that FDA may have to regulate health IT safety if the private and public sectors cant make su...

FDA Checking Quality of Compounded Makena

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FDA says it is analyzing compounded hydroxyprogesterone caproate products and the bulk APIs used to make them.

FDA Accepts QRxPharma NDA for Pain Drug

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FDA accepts for review a QRxPharma Limited 505(b)(2) NDA for MoxDuo (morphine and oxycodone) IR, indicated for treating moderate t...

Drop Waxman-Hatch Generics Incentive: Researchers

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The Generic Pharmaceutical Association blasts research funded by Pharmaceutical Research and Manufacturers of America calling on C...