OTC REVIEW's EXPECTATIONS FOR EFFICACY IN SWITCHES MAY IMPLY HIGHER STANDARD
This article was originally published in The Tan Sheet
OTC REVIEW's EXPECTATIONS FOR EFFICACY IN SWITCHES MAY IMPLY HIGHER STANDARD for such products versus prescription drugs, FDA Office of Drug Evaluation I Director Robert Temple, MD speculated at the Nonprescription Drug Manufacturers Association Research & Scientific Development Conference on Oct. 19. Temple hypothesized that "there is a different expectation" and perhaps a "higher standard" for "how effective an over-the-counter drug should be compared to a prescription drug" due to definitions for effectiveness found in OTC drug monograph regulations.
You may also be interested in...
Perrigo promotes in pricing, planning
Combe sells most of its OTC brands
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