FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA-483 from Compounding Firm Cites Microbial Contamination

[ Price : $8.95]

FDAs inspection of the pharmacy compounding operation at the center of the deadly meningitis outbreak cites significant microbiolo...

Ethicon Class 1 Recall of Surgical Staple Devices

[ Price : $8.95]

FDA says Ethicon has initiated a Class 1 recall of three surgical stapler devices because users have had difficulty firing the dev...

Tevas Synribo Approved for Leukemia

[ Price : $8.95]

FDA approves approveds a Teva Pharmaceuticals NDA for Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous...

FDA Denies Dispute Resolution on Watsons Prochieve

[ Price : $8.95]

FDA denies a Watson Pharmaceuticals formal dispute resolution request related to its pending NDA for Prochieve (progesterone vagin...

FDA Clears Medtronic Pediatric Cardiopulmonary Bypass

[ Price : $8.95]

FDA clears Medtronics Affinity Pixie Oxygenation System for cardiopulmonary bypass surgeries in neonates, infants and small childr...

Boehringer Agrees to Pay $95 Million Over Drug Marketing

[ Price : $8.95]

Boehringer Ingelheim Pharmaceuticals agrees to pay $95 million to the U.S. government to resolve allegations relating to improper ...

FDA Heeds Court Order, Approves Watson ANDA

[ Price : $8.95]

FDA complies with a federal court order and approves Watson Pharmaceuticals generic version of Actos (pioglitazone hydrochloride) ...

FDA Sets FY 2013 Backlog Fee

[ Price : $8.95]

Federal Register Notice: FDA sets FY 2013 rate for the backlog fee associated with human generic drugs.

Purdue Wants Rigorous Tests for Generic OxyContin

[ Price : $8.95]

Purdue asks FDA to require acceptable in vitro and in vivo test results on any generic OxyContin products.

FDA Raises Cardiovascular Risk with Novo Nordisks Degludec

[ Price : $8.95]

FDA says two Novo Nordisk NDAs for insulin products under review contain data showing a potential increased risk for cardiovascula...