FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Merck Slapped with 2 'Complete Response' Letters

[ Price : $8.95]

Merck receives two complete response letters for two NDAs under FDA review one on an oral contraceptive and the other on a glauco...

FDA Wont Ban Antibiotic Use in Food Animals

[ Price : $8.95]

FDA denies two citizen petitions asking it to ban all non-therapeutic uses of antibiotics in feed animal food and water.

Contaminated Pet Food from an Industry Too Big to Fail?

[ Price : $8.95]

Consulting editor John Scharmann traces the contamination of dry pet food with salmonella back to animal rendering plants, an indu...

CBO Sees Generic Drug Legislation Savings

[ Price : $8.95]

The Congressional Budget Office estimates a reduction in federal budget deficits of nearly $5 billion over 10 years from a bill to...

Former CDRH Compliance Head Lands at Consulting Firm

[ Price : $8.95]

Recently retired CDRH Office of Compliance director Tim Ulatowski joins Becker & Associates Consulting in the firms Washington, DC...

FDA, NephroGenex Agree on Surrogate Endpoint

[ Price : $8.95]

FDA and NephroGenex reach agreement on the design of a new Phase 3 Subpart H (accelerated approval) program that evaluates Pyridor...

Number of Monoclonal Antibodies Increasing

[ Price : $8.95]

The Tufts Center for the Study of Drug Development says that the number of monoclonal antibodies in clinical study has been steadi...

Should FDA Run Health IT?

[ Price : $8.95]

An Institute of Medicine report says that FDA may have to regulate health IT safety if the private and public sectors cant make su...

FDA Checking Quality of Compounded Makena

[ Price : $8.95]

FDA says it is analyzing compounded hydroxyprogesterone caproate products and the bulk APIs used to make them.

FDA Accepts QRxPharma NDA for Pain Drug

[ Price : $8.95]

FDA accepts for review a QRxPharma Limited 505(b)(2) NDA for MoxDuo (morphine and oxycodone) IR, indicated for treating moderate t...