Doc On Call? Cosmetic Manufacturers May Need M.D. On Retainer Under MoCRA
Cosmetic manufacturers may need to retain a medical professional to determine if adverse events they receive are minor or serious given the looming deadline for maintaining records and reporting serious adverse events to the US FDA, says Locke Lord partner David Abramowitz.
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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.
The Independent Beauty Association joins with Registrar Corp to provide IBA members with expert resources for preparing for deadlines under the Modernization of Cosmetics Regulation Act.
Cosmetics companies should not sit idly waiting for FDA to clarify new requirements under the Modernization of Cosmetic Regulations Act, speakers agreed at the Independent Beauty Association’s 2023 Technical/Regulatory Forum. Companies should be reviewing products, people and processes, including those of contract manufacturers, to get ahead of the curve.