FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Location for Design Controls Workshop Changed

[ Price : $8.95]

Federal Register Notice: FDA changes the location for a 4/4/08 public workshop on a QSR educational forum on design controls.

FDA OKs Pennfield Oil sNADA

[ Price : $8.95]

Federal Register Final rule FDA approves a Pennfield Oil Co. NADA for a zero-day preslaughter withdrawal time after use of oxytetr...

FDA Approves Elanco Animal Health sNADA

[ Price : $8.95]

Federal Register Final rule: FDA approves an Elanco Animal Health supplemental NADA for an increased monensin level in heifer feed...

Asian Carbamazepine Patients Need Genetic Test

[ Price : $8.95]

FDA says labeling for carbamazepine will add a recommendation that patients of Asian ancestry be genetically tested before startin...

Deaths in RF Lung Tumor Ablation

[ Price : $8.95]

CDRH cautions healthcare providers about deaths associated with off-label use of RF ablation devices.

FDA Panel Backs Cardiome Drug

[ Price : $8.95]

FDAs Cardiovascular and Renal Drugs Advisory Committee votes to recommend approval of Cardiome Pharma Corp.s NDA for Kynapid, an i...

Merck, Schering-Plough Back Off Vytorin Changes

[ Price : $8.95]

Reps. Dingell and Stupak ask Merck and Schering-Plough CEOs why they planned to change a Vytorin trial endpoint.

FDA Accepts ProEthics Migraine NDA

[ Price : $8.95]

FDA accepts a ProEthic Pharmaceuticals NDA for PRO-513 (diclofenac potassium), indicated for treating migraine headaches.

FDA Clears Medtronic Reveal Cardiac Monitors

[ Price : $8.95]

FDA clears a Medtronic 510(k) for Reveal DX and Reveal XT Insertable Cardiac Monitors (ICMs) intended for diagnostic monitoring of...

Marketing More Rewarding for Effective Drugs

[ Price : $8.95]

Researchers say drug effectiveness and side effects help determine the effectiveness of company marketing efforts.