Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model
Executive Summary
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.
You may also be interested in...
Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes
A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.
Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes
A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.
US FDA Drug Review Goals Should Be Faster In PDUFA VII, Industry Negotiators Propose
Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.