FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Beyond Surrogate Endpoints: Woodcock on Options

[ Price : $8.95]

CDER director Janet Woodcock tells an FDA workshop she has never liked the emphasis on surrogate endpoints in clinical trials, and...

Pfizer Settles Detrol Whistleblower Suit

[ Price : $8.95]

Pfizer agrees to pay $14.5 million to settle a whistleblower lawsuit alleging improper marketing of Detrol and Detrol LA.

FDA Accepts Neoprobe NDA fpr Lymphoseek

[ Price : $8.95]

FDA accepts for review a Neoprobe NDA for Lymphoseek (tilmanocept) for use in intraoperative lymphatic mapping.

Another Safety Alert on Zyvox, Methylene Blue

[ Price : $8.95]

A new FDA drug safety alert warns about a potential drug interaction between Zyvox or methylene blue and serotonergic psychiatric ...

FDA OKs Label Update for Prezista

[ Price : $8.95]

FDA approves a label update for Janssen Therapeutics' Prezista (darunavir) tablets to include 192-week data from the company's ART...

Public Citizen Urges FDA to Not Approve Imaging Dye

[ Price : $8.95]

Public Citizen reiterates its call for FDA to not approve Avid Pharmaceuticals experimental imaging dye florbetapir for use in dia...

CDRH Taking New Innovation Steps

[ Price : $8.95]

CDRH announces additional steps it is taking in the pre-market process to promote medical device manufacturer success through inno...

FDA Extends Tysabri sBLA Review

[ Price : $8.95]

FDA extends by three months its review of a Biogen Idec and Elan supplemental BLA for multiple sclerosis and Crohn's disease thera...

Baxter Warning Letter 'Closed-out'

[ Price : $8.95]

Baxter Healthcare says it has resolved GMP violations cited in a 1/20/11 Warning Letter involving its Jayuya and Guayama, Puerto R...

FDA Clears Canon Tonometer

[ Price : $8.95]

FDA clears a Canon USA 510(k) for the TX-20 Full Auto Tonometer for detecting glaucoma.