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Comments Submitted.pdf

22_0719_AHPA_Comments_to_FDA_re_NDIN_Guidance_FINAL.pdf
Preview of comments submitted
🔗 Source: ahpa.org
📊 Size: 135 KB
📄 Pages: 6 pages
⬇️ Downloads: 89

Summary

The American Herbal Products Association (AHPA) submitted comments to the FDA regarding the draft guidance on new dietary ingredients and dietary supplements subject to pre-market notification. AHPA supports the proposal to offer a 180-day period of enforcement discretion for late submission of NDINs and appreciates the flexibility in accepting postmarket safety data. However, AHPA recommends removing the estimate of 4,600 unsubmitted NDINs, as it is not based on evidence, and requests that FDA respond to NDINs within 75 days. AHPA also encourages FDA to provide an accurate address for NDIN submission and to prioritize issuing additional guidance on NDI notification procedures and timeframes before finalizing the draft guidance.

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Description

The American Herbal Products Association (AHPA) submitted comments to the FDA regarding the draft guidance on new dietary ingredients and dietary supplements...

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  • File Format: PDF
  • File Size: 135 KB
  • Pages: 6
  • Language: EN
  • Total Downloads: 89
  • Last Updated: 1 week ago

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