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.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning