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Pre-ANDA Meeting Goals May Be Created In GDUFA II

This article was originally published in The Pink Sheet Daily

Executive Summary

Idea could help sponsors of complex generics, but will it extend to other ANDAs?

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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.

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.

GDUFA II Will Include Small Business Relief, Priority ANDA Reviews

Generics industry and FDA have resolved remaining issues regarding financing of user fee program.

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