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...
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.
US FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals
Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.
US FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals
Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.