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CDRH Seeks Predictability in Applying New Science to Decisions

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CDRH schedules a public meeting at which to receive input on how it can better adapt to using new science in regulatory decisions.

Auxilium to Meet with FDA on Xiaflex Trial

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Auxilium says it plans to meet with FDA in the second quarter of next year to review recent Phase 2 data and discuss a Phase 3 cli...

ANADA Sponsor Changed to Bioniche Teoranta

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Federal Register Final rule: FDA amends the animal drug regulations to change a sponsor for ketamine HCl to Bioniche Teoranta.

State Insurance Commissioner Tapped as FDA Chief Counsel

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Maryland insurance commissioner Ralph S. Tyler joins FDA next month as the agencys chief counsel.

Advisors Nix Expanded Tarceva Indication

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Members of FDAs Oncologic Drugs Advisory Committee recommend against an expanded indication for OSI/Roches Tarceva.

Industry Easily Beats Import Amendments

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Supporters of drug importation blame drug companies and the Obama administration for its defeat in the Senate.

Advisors Back New Crestor Indication

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Members of FDAs Endocrinologic and Metabolic Drugs Advisory Committee vote 12-4-1 to recommend approval of an expanded indication ...

FDA OKs Intervet Bovine Treatment

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Federal Register Final rule: FDA approves an Intervet, Inc. supplemental NADA to add Mycoplasma bovis as a pathogen for which flor...

Medicines Co. Recalls 11 Lots of Cleviprex

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The Medicines Co. recalls 11 lots of Cleviprex (clevidipine butyrate) injectable emulsion due to the potential presence of visible...

ICH S6 Addendum Published

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FDA publishes an addendum to the ICH S6 guidance on safety evaluation of biotechnology-derived drugs.