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Tuesday, 24th April 2012

Advances in FDA's Safety Program for Marketed Drugs

Source: U.S. Food and Drug Administration

From the press release:

A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as to premarket drug review.

The report says CDER is also delivering earlier, more effective drug safety information to the public to protect patients from harm. In 2011, CDER issued 68 drug safety communications – up from 39 in 2010. The communications provide early information to patients and health care professionals about drug safety issues as they emerge.

+ Direct link to full report (PDF; 187 KB)

+ Direct link to Drug Safety Highlights and Safety Science & Research Report (HTML)


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An Info Pro, librarian, entrepreneur, author, worldwide connector and book-lover, Heather Negley is recognized for her new ways of thinking about librarianship, research, social media and creativity. Heather is the founder of HelpALibrarian.com and Zing Information Services. She has most recently been an Information Research Specialist with the Congressional Research Service at the Library of Congress where she provided business research for members of Congress and their staffs. Heather also worked as a research reporter for U.S. News and World Report and as a technical advertising producer on the washingtonpost.com. She received her MS in Library and Information Science from Simmons College in Boston, MA.

Heather can be reached at heather.negley@freepint.com

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