Regulations

FDA Draft Guidance: Records Access Authority for Cosmetic Products

Focus on adverse events, SAHCOD and inspections, with comments due March 23.

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By: Christine Esposito

Editor-in-Chief

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On Jan. 21, the US FDA issued draft guidance on its authority to access and copy records related to cosmetic products under sections 605, 610, and 704 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act). Those sections are: 605 (adverse event reports); 610 (serious adverse health consequences or death to humans; SAHCOD); and 704 (inspections) of the FD&C Act. The draft guidance can be accessed here. Submission of electronic or written comments on this d...

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