Comparative efficacy data for new drugs, devices not required, FDA clarifies.
This article was originally published in The Tan Sheet
Executive Summary
COMPARATIVE EFFICACY DATA NOT REQUIRED IN NDAs and medical device premarket approval applications, FDA stated in an Aug. 1 Federal Register notice. Indicating that the document is a clarification of existing policy, FDA spelled out: "The agency does not require new human drug products or medical devices to be more effective than existing therapies nor does it necessarily require the product be compared to other products." Public comments on the statement must be submitted by Oct. 30.
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