FDA Combines Supplement GMP Recordkeeping, Testing Waiver Estimates
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CRN communications chief Wommack; has law background; NPA says FDA missed Bergstrom Nutrition's skip lot petition; AHPA approaches member review in "Herbs of Commerce" update.
Like FDA's draft guidance on NDI notifications and its previous estimates for compliance with that regulation and the GMP final rule, the agency's latest estimate on manufacturers' annual burdens associated with GMP recordkeeping prompts industry questions.