Although drugs undergo safety tests prior to approval, sometimes harmful effects do not become apparent until a product has been on the market for a while and has been used by a larger, more diverse population. Ethical and Scientific Issues in Studying the Safety of Approved Drugs, a new report from the Institute of Medicine, offers the U.S. Food and Drug Administration guidance on developing a more systematic and transparent process to collect, assess, and act on data about medications’ benefit-risk profiles throughout their entire "life cycle" from approval until they are no longer marketed.
Advance copies of the report will be available to reporters only beginning at 11 a.m. EDT Monday, April 30. The report is embargoed and not for public release until 11 a.m. EDT Tuesday, May 1. To obtain a copy or arrange an interview with a member of the authoring committee, contact the Office of News and Public Information; tel. 202-334-2138 or e-mail email@example.com.