ANDA Expedited Review Criteria MaPPed Out By FDA Generic Drug Office
CDER staff manual outlines seven categories of submissions that can qualify for expedited review, including some ANDAs with patent certifications and supplements that have the potential to create an “extraordinary hardship” for a sponsor if not addressed quickly.
You may also be interested in...
New pathway could restart argument between industry and FDA over what qualifies for expedited review.
Generic drugs office will proactively seek litigation and other information that could affect launch timing.
Office of Generic Drugs wants to allow project managers to inform sponsors of major deficiencies before ‘complete response’ letter as part of ‘go/no go’ effort.