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Agency says updated instructions for MedWatch Form 3500A make it easier to report a SAE.
December 15, 2023
By: Christine Esposito
Editor-in-Chief
The US Food and Drug Administration (FDA) has provided an update on ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are enforceable starting December 29, 2023. FDA has updated the instructions for MedWatch Form 3500A to make it easier for the industry responsible person to complete the form to report a serious adverse event for a cosmetic product. The link to the updated PDF can be accessed here. ...
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