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MoCRA Updates: US FDA Unveils the Draft Guidance for Cosmetic Facility Registration and Product Listing

Aug 11, 2023
Winnie Xu
The draft guidance provides comprehensive direction on facility registration and product listing, covering responsible entities for application submission, necessary dossiers, submission methods, submission deadlines, etc.

The scheduled launch of the new submission portal is set in October 2023, with the FDA open for applications for user acceptance testing.

FDA has adopted the Establishment Identifier (FEI) as the facility registration number, a prerequisite for the upcoming product listing submission.
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Tags : Pre-market ApprovalUSMoCRA
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