By Derrick Gingery
US Food and Drug Administration officials hope changes to the ANDA pre-submission meeting will create more value and generate more complex generic sponsor interest, which could lead to faster approvals. Pre-submission meetings allow an ANDA sponsor to discuss the structure of an upcoming submission with FDA assessors and highlight areas with unique or novel data or identify key studies used in the development program.
One of the major goals, as with the prior reauthorization, is increasing first-cycle application approvals. A new post-complete response letter scientific meeting was created for sponsors to receive advice on alternative approaches to addressing deficiencies. Dive in to the many more communication enhancements in GDUFA III.