FDA first-party audit program voluntary participation needs added incentives -- industry.
This article was originally published in The Tan Sheet
Executive Summary
FIRST-PARTY AUDIT PROGRAM FOR SELF-REPORTED GMP COMPLIANCE requires greater incentives to encourage voluntary participation, drug industry representatives told FDA at an "industry exchange" meeting in Washington, D.C. June 23. FDA announced the Good Manufacturing Practices modified inspection pilot program April 14 ("The Tan Sheet" April 20, p. 24). The program would enable firms with solid quality assurance processes to be subject to less extensive agency inspections.
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