expedited review of application
- Guideline or reference source
- FDAGDUFA Generic Drug User Fee Amendments 2012
- Definition
- While generally, review of original ANDAs, ANDA amendments and ANDA supplements are reviewed in the order received, (first-in, first-reviewed), certain applications may be identified at the date of submission for expedited review, as described in CDER’s MAPP 5240.3. (See http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm079787.pdf3) which includes expedited review of the orginial submission and amendment(s) associated with the expedited review qualifying application. Products to respond to current and anticipated public health emergencies, products under special review programs, such as the President’s Emergency Plan for AIDS Relief (PEPFAR), products for which a nationwide shortage has been identified, and first generic products for which there are no blocking patents or exclusivities on the reference listed drug currently may qualify for expedited review. For ANDAs in the year 1 and 2 cohorts, FDA will expedite review of Paragraph IV applications that are submitted on the first day that any valid Paragraph IV application for the drug in question is submitted.
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