Biosimilar User Fee Meeting Schedule Allows FDA Data “Pre-Review”
Executive Summary
Agency officials are willing to meet with sponsors during their development programs to look at data and provide advice in part to ensure they remain on track, but also to promote a high first-cycle approval rate.
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Complex ANDAs To Be Allowed Pre-Submission Product Meetings
FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.