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Device Panel Votes Down CardioMEMS Heart Monitor

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FDA's Circulatory Systems Devices advisory panel votes 6 to 4 to not recommend approval of a CardioMEMS PMA for the Champion Heart...

'Emerging Sponsors' Wreak Havoc on CDER Operations: FDAer

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CDER Office of New Drugs Director John Jenkins tells an industry audience that emerging sponsors are wreaking havoc on review acti...

FDA Panel Backs Ortho Evra; Asks for Clearer Labels

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An FDA advisory committee votes that the benefits of Janssen Pharmaceuticals Ortho Evra (norelgestromin/ethinyl estradiol transder...

Sunesis Pharma Continues with AML Trial After DSMB Review

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Sunesis Pharmaceuticals says it is continuing a Phase 3 trial of vosaroxin in acute myeloid leukemia patients after receiving a f...

Sen. Coats Bill Would Reform FDA's Mission

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Sen. Dan Coats (R-IN) introduces a bill to clarify and reform FDA's mission in order to keep jobs from going overseas.

FDA OKs Elanco sNADA for Bovine Respiratory Disease

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Federal Register Final rule: FDA approves an Elanco sNADA for using tilmicosin for controlling bovine respiratory disease in group...

FDA Publishes Candidates for Performance Review Board

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Federal Register Notice: FDA publishes a list of members that may be named to its Senior Executive Performance Review Board.

Dako, Genentech Collaborate on Drug for Breast Cancer

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Dako and Genentech sign an agreement to collaborate on regulatory submissions to FDA for Dakos companion diagnostics for a Genente...

FDA Defends Extra 2 Months to Review PDUFA Submissions

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FDA defends a two-month extension in PDUFA submission review times under a proposed agreement reauthorizing the user fee program.

Peginesatide Recommended by Panel

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FDAs Oncologic Drugs Advisory Committee says that Affymax and Takedas peginesatide is effective in treating dialysis patients with...