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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.

Drug Companies Cutting Sales Staffs

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Reuters reports that many drug companies in the U.S. and Europe are cutting the number of sales reps as doctors lose influence ove...

ICH Guidance on Capillary Electrophoresis

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Federal Register Notice: FDA releases an ICH draft guidance, Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in t...

ICH Guidance on Analytical Sieving General Chapter

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Federal Register Notice: FDA releases an ICH draft guidance, Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in t...

Panel to Discuss Non-Hodgkins Lymphoma NDA

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 2/10 to discuss Cell Therapeutics NDA for Pixuvri to tr...

Public Workshop on Clinical Trial Requirements

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Federal Register Notice: FDA Florida District and the Society of Clinical Research Associates will hold a public workshop 3/3-4/10...

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.

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.