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...

Insight Pharma Recalls Nasal Decongestant

[ Price : $8.95]

Insight Pharmaceuticals recalls one lot of Nostrilla Nasal Decongestant nasal spray because it may contain Burkholderia cepacia.

FDA OKs Watsons Lower Dose Testosterone Patch

[ Price : $8.95]

FDA approves Watson Pharmaceuticals Androderm 2 mg and 4 mg testosterone patch indicated as testosterone replacement therapy in ma...

FDA OKs Ferring Euflexxa Osteoarthritis Labeling

[ Price : $8.95]

FDA approves a Ferring Pharmaceuticals labeling supplement for Euflexxa to include data from a 26-week safety and efficacy trial c...

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...