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Rule on Price Info in DTC Ads Illegal: WLF

[ Price : $8.95]

Washington Legal Foundation senior counsel Cory Andrews says FDA lacks authority to implement an HHS proposal to force drug manufa...

New Warning Added to Diabetes Drugs

[ Price : $8.95]

An FDA drug safety alert warns that cases of a rare and serious infection of the genital area have been reported with sodium-gluco...

Zimmer Biomet Warning Letter Posted

[ Price : $8.95]

FDA releases an 8/24 Zimmer Biomet Warning Letter that the company disclosed last week.

Complete Response Letter on Rare Disease Drug

[ Price : $8.95]

Ionis Pharmaceuticals and its affiliate Akcea Therapeutics receive an FDA complete response letter rejecting an NDA for Waylivra (...

CDER Promotes Deputy Slack to Head Strategic Programs

[ Price : $8.95]

CDER promotes Office of Strategic Programs deputy director Mary Slack to permanent director.

FDA Tells 21 Web Sites to Stop Selling Opioids

[ Price : $8.95]

FDA tells four more online networks operating 21 Web sites to stop selling unapproved and misbranded versions of opioid drugs.

Recognize Auryxia Regulatory Exclusivity: Keryx Petition

[ Price : $8.95]

Keryx asks FDA to recognize two forms of exclusivity for its Auryxia ferric citrate drug.

FDA Clears Add-on to Ceterix Orthopedics Meniscal Repair

[ Price : $8.95]

FDA clears a Ceterix Orthopedics 510(k) for an added feature to the NovoStitch Pro Meniscal Repair System a size 0 suture cartrid...

Haemonetics Recalls 10 Lots of Leukotrap RC System

[ Price : $8.95]

Haemonetics recalls 10 lots of their Leukotrap RC System with RC2D Filter, intended for collecting whole blood and preparation of ...

False, Misleading EstroGel Sell Sheet: OPDP

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says a professional sell sheet for Ascends EstroGel contains false and misleading clai...