AERs sufficient support for FDA ephedrine proposed rule, agency tells Rep. Shays.
This article was originally published in The Tan Sheet
Executive Summary
EPHEDRINE SUPPLEMENT AERs ADEQUATE GROUNDS FOR PROPOSED RULE, FDA says in a May 21 response to questions from Rep. Christopher Shays (R-Conn.) about the use of adverse event reports in the ephedrine alkaloids rulemaking process. The agency letter addresses Shays' concerns about setting an inappropriate rulemaking precedent with the use of AERs by citing other examples where the reports were used in rulemakings. Shays chairs the House Government Reform/Human Resources Subcommittee.