FDA posts safety info on new drugs

The Daily Record Newswire The Food and Drug Administration has announced that it will begin posting safety data on recently approved drugs and biologics on its website in an effort to better educate patients and health care professionals. The agency released safety summaries on 26 approved drug products based on reports from manufacturers, consumers and others who have used products since they were approved to market. The summaries include safety problems and adverse events that have been reported in association with each drug, as well as any actions or surveillance activities the agency has undertaken in response to the reports. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the FDA to prepare the safety summaries within 18 months after a product's approval or after it has been used by 10,000 patients, whichever comes later. ''These summaries will provide clear and useful information in a timely manner that can be used by providers and patients to make informed decisions about an individual's health,'' said Dr. Robert Ball, director of the FDA's Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research. The information that the summaries are based upon comes from reports made to the FDA's Adverse Event Reporting System, the Vaccine Adverse Event Reporting System maintained by the FDA and the Centers for Disease Control and Prevention, periodic safety information manufacturers submit, medical literature and data from ongoing studies. Published: Mon, Jul 12, 2010

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