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Latest FDA News and Information

FDA approves Inlyta to treat patients with a type of advanced kidney cancer

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this... read more

Department of Justice files Consent Decree of Permanent injunction against Ranbaxy

Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities

Maine company holds cold smoked salmon product after FDA order

A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within... read more

FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri

Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in... read more

Food and Drug Adminstration (FDA): CDRHNew

FDA Report on MDUFMA / MDUFA Performance, October 21, 2011 (PDF)

FDA Report on MDUFMA / MDUFA Performance, October 21, 2011

Summary Information for: MelaFind®

Labeling, Approval Order, and Summary of Safety and Effectiveness for MelaFind® (P090012).

Federal Register: Pediatric Medical Devices; Public Workshop; Reopening of Comment Period

The FDA is reopening until March 5, 2012, the comment period for the notice entitled Pediatric Medical Devices; Public Workshop; Request for Comments that appeared in the Federal Register of Tuesday, November 1, 2011 (76... read more