FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

'Emerging Sponsors' Wreak Havoc on CDER Operations: FDAer

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA OKs Elanco sNADA for Bovine Respiratory Disease

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Sunesis Pharma Continues with AML Trial After DSMB Review

[ Price : $8.95]

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

[ Price : $8.95]

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

Reviewers Raise Adasuve Safety Concerns

[ Price : $8.95]

FDA medical reviewers ask members of the Psychopharmacologic Drugs Advisory Committee to determine whether the benefits of Alexzas...

Plan B Decision Supports Authoritarian Control of America

[ Price : $8.95]

Editor Jim Dickinson sees in HHS secretary Kathleen Sebelius decision to over-rule FDA on Plan B a continuation of Bush-era author...