Just weeks from the deadline for reporting serious adverse events (SAEs) under the Modernization of Cosmetics Regulation Act, the US Food and Drug Administration has updated instructions for filing reports to make the process easier, while promoting a soon-to-launch electronic submission platform.
Though the 14 December notice does not specify how the instructions for using the MedWatch Form 3500A are simplified, it reminds the designated responsible person under MoCRA –...
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