OTC "material time, material extent" tentative criteria allow drug export countries' data.
This article was originally published in The Tan Sheet
Executive Summary
FDA "MATERIAL TIME, MATERIAL EXTENT" CRITERIA FOR OTCs would allow acceptance of foreign marketing data from countries designated as appropriate recipients of U.S. drug exports under the recently revised Drug Export Amendments of 1986, according to an Oct. 3 FDA Federal Register notice. Australia, Canada, New Zealand and the U.K. are among the 24 "tier one" countries under the drug export law. FDA is interested in feedback on whether marketing experience from countries outside that list also should be considered.
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