draft guidance
FDA Releases Draft Guidance on Registration of Cosmetic Product Facilities and Listings
The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing its plans for the registration of cosmetic product facilities and listing of cosmetic products, two new regulatory requirements applicable to many cosmetic products and their manufacturers under the Modernization of Cosmetics Regulation Act (MoCRA). There are no fees associated with product listing or ...
CRN Responds to FDA’s NDI Announcement
On May 19, FDA announced in draft guidance the agency’s intent to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification. Council for Responsible Nutrition (CRN) President and CEO Steve Mister expressed the following thoughts on the ...
FDA Releases Revised Draft of NDI Guidance; AHPA Convenes Working Group for Comments
The Food and Drug Administration (FDA) today released revised draft guidance for new dietary ingredients (NDIs) to be published in the Federal Register on Friday, Aug. 12. The revised draft replaces FDA’s 2011 draft. The guidance, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” is subject to a 60-day comment period. ...
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