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FDA Moving on Ethicon Sedasys Appeal

[ Price : $8.95]

FDAs Office of the Commissioner says it will hear Ethicons appeal of the CDRH decision that the companys Sedasys PMA is not approv...

Report Notes FDA Slowness in Reviewing Post-marketing Studies

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A new report by Booz Hamilton shows that FDA is slow to review the final study reports required by post-marketing requirements and...

Echo Files 510(k) for Prelude Skin Prep

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Echo Therapeutics files a 510(k) with FDA for the Prelude SkinPrep System and 4% lidocaine cream for transdermal drug delivery.

Dendreon BLA Supplement for Increased Provenge Manufacturing

[ Price : $8.95]

Dendreon submits a BLA supplement to increase the manufacturing capacity for Provenge (sipuleucel-T) at its Morris Plains, NJ manu...

FDA Backs Menerba Clinical Development Plan

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FDA tells Bionovo that it supports the companys overall clinical development plan for Menerba to treat menopausal hot flashes.

Court Rejects Actavis Vyvanse Appeal

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A DC Appeals Court ruling dismisses an Actavis claim that FDA should not enforce five years of marketing exclusivity for Shires Vy...

Trial in U.S. Begins with New Antibiotic Class

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FDA approves a PolyMedix IND for PMX-30063, a synthetic defensin-mimetic antibiotic to initiate a Phase 1 clinical trial in the U....

Industry Fears FDA Budget Cuts: Zeneca CEO

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AstraZeneca CEO David Brennan tells the Reuters Health Summit that significant cuts in taxpayer funding for FDA could mean slower ...

CDRH Pilot Posting of De Novo Letter

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CDRH begins posting de novo classification letters to help medical device sponsors better understand how a device without a predic...

FDA Classifies Tissue Adhesive into Class 2

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Federal Register Final rule: FDA classifies the tissue adhesive with adjunct wound closure device intended for total approximation...