CDER Is Stressing Consistency As It Rolls Out FDASIA Programs
Senior officials from FDA’s drugs center say they are working to ensure that a revamped review model for new molecular entities and the “breakthrough therapy” designation program are consistently applied across review divisions.
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A few requests have gone to FDA for candidates to be named breakthrough therapies and gain access to shorter development programs, but the agency has not established all the program requirements yet.
OND Director John Jenkins says the late-cycle meeting in the new PDUFA review model will offer a lot of information to sponsors, but likely will not be predictive of application approvability.
CDER Director Janet Woodcock is creating an executive-level forum to deliberate medical policies, including those needed to smooth drug reviews. She envisions stakeholder input on topics for discussion by the panel.