Some Long-Standing FDA Regs Face Mandatory Review Or Rescission Under New HHS Rule

Among those judged eligible are FDA rules governing adverse event reporting and the Unique Device Identification System.

rules and regulations marked on rubber stamp
Former FDA Commissioner Scott Gottlieb said the HHS regulation review rule imposes paperwork requirements that could impede agency work. • Source: Shutterstock

Regulations governing adverse event reporting and manufacturing facility registration must be reviewed and potentially updated by the US Food and Drug Administration or face rescission.

The Health and Human Services Department on 8 January announced that it will finalize a proposed rule requiring many regulations to be regularly assessed to determine whether they remain relevant and need updating. Under the

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