Pharma groups suggest modification to FDA’s CGT postapproval guidance
Regulatory NewsJoanne S. Eglovitch
Advanced therapies/cell and gene therapyDecentralized clinical trialsHuman cells, tissues, and cellular and tissue-based products (HCT/Ps)ICHPharmacovigilancePostmarketing requirement/postmarketing commitmentRegulatory harmonizationRegulatory Intelligence/PolicyUnited StatesUS Food and Drug Administration (FDA)