Topic: Center for Drug Evaluation and Research

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who...

FDA Creates Shared REMS System for TIRF Medicines

On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, a single-shared risk evaluation and mitigation strategy (REMS) for transmucosal...

FDA Revamps to Meet New Challenges

Pressure to spur development of new medical products, deal with an increasingly global pharmaceutical supply chain, and accomplish more tasks with...
The outcry from physicians, pharmacists, and patients over disruptions in the supply of vital medicines to treat cancer, pain, and other serious...
Posted on 09/26/11 at 12:22pm by Benzinga Staff . SILVER SPRING, Md., Sept. 26, 2011 /PRNewswire-USNewswire/ -- In 2010, there were a record number...
Posted on 09/12/11 at 11:22am by Benzinga Staff . Review divisions to be aligned by expertise, disease-specific areas. . SILVER SPRING, Md., Sept...

The Labeling of Medical Air

Basic Requirements Medical gas labels are required to include the manufacturer or distributor's name and address, the name of the product, the measurement of the contents (such as liters), the lot number and the ingredients. If the violation continues, a recommendation ...

American Reprographics Sees Red

American Reprographics Company is down 15.75% today after the company lowered its EPS and operating cash flow projections on weaker-than-expected demand for reprographics services.. Alexza Pharmaceuticals is down over 54% after receiving a complete response letter issued by the FDA's ...
This post is a long one but I promise it's worthwhile for the Arena (ARNA) crowd. In order to more accurately determine the potential outcome of the Lorqess advisory committee meeting on September 16, I wanted to review the comments to ...
McNeil Consumer Healthcare has recently expanded its voluntary recall of some over-the-counter drugs to include about 500 lots of products, according to officials from the Office of Compliance in the Center for Drug Evaluation and Research at the U.S. Food and ...