FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Rep Cited for False, Misleading Latuda Statements

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says that a Sunovion sales representative made false or misleading statements about La...

OPDP Says Qutenza Booth Didnt Give Risk Info

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says that a convention display booth for NeurogesX Qutenza failed to communicate risk ...

Gilead Submits Truvada sNDA for New Indication

[ Price : $8.95]

Gilead says it is seeking a new indication for Truvada for pre-exposure prophylaxis to prevent HIV-1 infection.

ProstaScint Fact Sheet Misleading: OPDP

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says an EUSA ProstaScint fact sheet fails to provide important information, overstates...

FDA Not Requiring REMS for Cushings Drug

[ Price : $8.95]

FDA tells Corcept Therapeutics that it will not require a Risk Evaluation and Mitigation Strategy program as part of its NDA submi...

FDA Clears Critical Diagnostics ST2 Assay

[ Price : $8.95]

FDA clears a Critical Diagnostics 510(k) for the Presage ST2 Assay for use as an aid in assessing the prognosis of patients diagno...

CMS Delays Gift Recording Requirement

[ Price : $8.95]

CMS delays the deadline for drug, medical device, and biologics manufacturers to report payments of more than $10 they make to doc...

Senators Introduce Medical Device Patient Safety Act

[ Price : $8.95]

U.S. senators Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduce the Medical Device Patient Safety Ac...

Federal Reserve Model for Independent FDA?

[ Price : $8.95]

Harvard professor Daniel Carpenter calls for an independent FDA similar to the Federal Reserve to avoid future presidential interf...

FDA Designates Photofrin as Orphan Drug

[ Price : $8.95]

FDA gives Pinnacle Biologics Photofrin orphan drug status as adjuvant therapy for malignant pleural mesothelioma.