Drug safety alerts almost double

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An FDA report says the agency issued 68 drug safety alerts in 2011, an average of more than one each week and up 74% over the 39 alerts issued in 2010.

The report focuses on how FDA has been strengthening its drug safety science, citing efforts “to bring drug chemistry and pharmacology to bear on understanding drug safety.”

Under FDA's “equal voice” initiative, it has modified its reporting structure so the directors of CDER's Office of Surveillance and Epidemiology and the Office of New Drugs (OND) each report directly to CDER director Janet Woodcock—a change that “helped establish parity between these two important offices,” the report says.

In 2007, the FDA Amendments Act (FDAAA) gave FDA authority to require postmarket safety studies and clinical trials at the time of or after a drug's approval. FDAAA also let the agency require a change in a drug's label to include new safety information.

Since 2008, FDA has required new safety labeling 65 times, generally for whole classes of drugs. FDA published a draft guidance on implementing this authority in April 2011.

In CDER's Office of Generic Drugs (OGD) the agency established a postmarket surveillance and safety team within the Division of Clinical Review.
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