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FDA: 35 Innovative New Drugs Approved in Fiscal Year 2011
Date:11/3/2011

legislative authority for PDUFA expires on Sept. 30, 2012.  

"Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy."

In October 2011, the FDA released a new plan, Driving Biomedical Innovation: Initiatives to Improve Products for Patients, to assist companies engaged in new product development, particularly smaller, entrepreneurial companies.

In a separate action, the agency also released a report this week on drug shortages, expanded its current actions to address the problem, and, at the direction of the President, will broaden early notification of drug shortages and work with the Department of Justice to prevent price gouging.

For information:  

Report on FY 2011 Innovative Drug Approvals
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm

Driving Biomedical Innovation:  Initiatives to Improve Products for Patients
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm274333.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, '/>"/>

SOURCE U.S. Food and Drug Administration
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