Sticking With The Program: PDUFA V Review Changes Appear To Be Working
Pharmaceutical Approvals Monthly’s annual Drug Review Profile series illustrates how the “program” enhancements to the review process have made the regulatory process easier for sponsors.
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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.
The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.
Deal Snapshot: The firms are partnering on a digital therapeutic for schizophrenia in a deal potentially worth $500m.