FDA’s Linda Katz Takes MoCRA Questions At IBA Regulatory Workshop
The director of FDA’s Office of Cosmetics and Colors addressed questions on the responsible person required by the Modernization of Cosmetics Regulations Act, safety substantiation, adverse event reporting and more at the IBA virtual event.
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In comments on FDA draft guidance released in August, industry members raise questions about the agency’s capacity to deal with an anticipated flood of facility registrations and product listings. Confidentiality and international trade also figure among concerns.
Jessica O’Connell, partner at Covington & Burling, is getting questions from clients about the electronic system the FDA plans to launch in coming weeks for cosmetics manufacturers to register facilities and list products as required by new cosmetics regulations. It remains to be seen how hard the 29 December 2023 deadline will be for companies to get their information submitted.
Companies preparing for adverse event reporting and recordkeeping deadlines on 29 December under new cosmetics regulations should ensure they have systems in place for netting complaints across media, triaging reports, and making speedy weight-of-evidence determinations, said SafetyCall International’s Rick Kingston at IBA’s recent FDA regulatory workshop.