PDUFA V: FDA Relaxes Pre-Submission Meeting Requirement
Sponsors may have negotiated a four-month reprieve for the required pre-submission meeting in the proposed new application review system expected to be implemented with PDUFA V.
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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.