Questions about the efficacy or safety of medications can arise after they have been approved for the market and may require further clinical investigation.
"Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report," new from the Institute of Medicine, offers recommendations to help the U.S. Food and Drug Administration evaluate the ethical issues involved in determining whether companies should start or continue such trials and in ensuring that these studies are conducted appropriately.
The report is the start of an ongoing review of ethical and scientific issues related to studying the safety of drugs on the market.
Advance copies will be available to reporters only beginning at noon EDT Thursday, July 8. THE REPORT IS EMBARGOED AND NOT FOR PUBLIC RELEASE BEFORE 9 A.M. ON FRIDAY, JULY 9. To obtain a copy of the report, contact the Office of News and Public Information; tel. 202-334-2138 or e-mail news@nas.edu.