OTC office would have sole responsibility for Rx-to-OTC switches under PhRMA draft bill.
This article was originally published in The Tan Sheet
Executive Summary
FDA OTC OFFICE WOULD HAVE SOLE RESPONSIBILITY FOR Rx-TO-OTC SWITCHES and all other matters related to OTC drugs under draft FDA reform legislation recently prepared by the Pharmaceutical Research and Manufacturers of America (PhRMA). The draft legislation states that "all applications or petitions requesting that a drug be switched from prescription to nonprescription status and all other matters relating to nonprescription drugs shall be reviewed and acted upon solely by a single office in the center for drugs, and that office shall report directly to the center director."
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