The FDA announced Tuesday that it will begin posting to its website summaries of the safety risks of recently approved drugs. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research, commented that the summaries provide "an early detection mechanism for potentially serious risks and complements the FDA’s analysis of safety data during drug development and the agency’s routine monitoring of safety information after product approval."
The summaries, which will be based on reports by manufacturers, providers, consumers and others to the FDA’s adverse event reporting system could include information on any potentially serious, previously unidentified risks, as well as known side effects that occur more often than during clinical studies. The postings will also include an overview of any steps the agency is taking to address these issues.
According to the agency, the summaries will be prepared within 18 months of a product’s approval, or after a drug has been used by 10 000 patients, whichever comes later. The first summaries will be based on drugs approved since September 2007.
Reference Articles
 Drugs' risks emerging after clinical trials to be shown on US website - (Bloomberg) |
| FDA to communicate safety monitoring activities to consumers and health care professionals - (FDA) |
| US FDA to post risk summaries for newer drugs - (Interactive Investor) |
| FDA to post safety issues online for new drugs - (MSNBC) |
| FDA releases first set of drug, biologic safety reviews (free preview) - (The Wall Street Journal) |
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