FDA Supplement GMP Recordkeeping Estimate Fails Industry Proofread
This article was originally published in The Rose Sheet
Like FDA's draft guidance on NDI notifications and its previous estimates for compliance with that regulation and the GMP final rule, the agency's latest estimate on manufacturers'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.
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FDA didn't change its estimates for industry's annual regulatory burden – 929,140 hours – from compliance with recordkeeping requirements in supplement GMPs, its estimates of eight hours needed to prepare a request for exemption from identity-testing requirement also in unchanged.
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More than four years after beginning to revise its widely criticized initial draft guidance on NDI notifications, FDA on Aug. 11 released a second draft. "I think it is reflective of a new effort by the agency to have a dialogue with the industry," says Steve Mister, president and CEO of the Council for Responsible Nutrition.