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FDA Combines Supplement GMP Recordkeeping, Testing Waiver Estimates

 
• By Malcolm Spicer

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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The US Food and Drug Administration combined its estimates on separate parts of dietary supplement firms' regulatory burden from good manufacturing practices requirements in 2020, though the Natural Products Association ays the agency continues underestimating the costs.

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