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How does FDA monitor safety after drugs are approved and marketed?

FDA's safety assessment of medicines does not diminish after drugs are approved for marketing. Although the premarket phase of study is very intensive, much work still remains to monitor approved drugs over time. No drug is risk-free, and it is not uncommon for new information to be discovered after a drug is on the market and being used by larger numbers of patients. Such information helps provide a better picture of drug risks, enables FDA to give health care professionals and patients the latest information on potential or newly identified risks, and strengthens FDA's ability to safeguard patients against unacceptable risks.

In recent years, FDA's Center for Drug Evaluation and Research (CDER) has taken many steps to enhance the quality, accountability, and timeliness of its postmarket drug safety decisions. As a result, the Agency now oversees the safety of marketed drugs with the same emphasis it has for premarket drug review. These efforts include the development of important new scientific tools to enhance detection of potential drug safety issues that occur once a drug is on the market and new methods for planning, managing, tracking, and communicating about those issues.

Visit this link for a complete 21-page April 2012 report of FDA's Center for Drug Evaluation's work to enhance the Agency's postmarket drug safety. Visit this link for a six-page highlights version of the same report.

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