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Not efficacy....

Efficacy is not a word in our industry. My opinion is all the regs hang on Identity, purity (strength)and safety. Efficacy is not a requirement, and the FDA just got spanked for requiring clinical trials for label claims. Efficacy is 21 CFR Part 211, not 111....

Posted by Steve Baugh
30 May 2012 | 21h36

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Back to: Safety & efficacy – The industry’s mission statement in two small words

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