Part 11 Industry Participation Advocated To Solve FDA Scope Issue
This article was originally published in The Tan Sheet
Executive Summary
Industry should play a large role in determining when particular documents should be covered under the electronic records and electronic signatures regulation, according to a proposal submitted to FDA by the Industry Coalition on 21 CFR Part 11
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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
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