REMS Reform Looks To Be Theme Of PDUFA V: Stakeholders Call For Standardization, Earlier Notice
The biggest changes that came out of the FDA Amendments Act, the last round of Prescription Drug User Fee Act reauthorization, were FDA's augmented drug safety authorities, most specifically the Risk Evaluation and Mitigation Strategy tool. Going into the next round of PDUFA negotiations, a major focus will be on improving the implementation of the REMS program
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The struggles that industry and FDA face when trying to best standardize and evaluate REMS are illustrated by the dozens of topics jammed into the two-day meeting.
Brookings’ Engelberg Center for Health Care Reform invited to help FDA research REMS and risk-benefit standardization, patient-reported outcomes, and other issues that were mandated in PDUFA V.
NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.