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GPhA Pushes REMS Pay-for, Schedule III Hydrocodone In User Fee Bill

This article was originally published in The Pink Sheet Daily

Executive Summary

Generic association had officially been agnostic in the choice between House’s pay-for, which would speed biosimilar petition review, and the Senate provision, which ensures access to REMS products for ANDA development. But a letter to Congress now formally outlines GPhA’s hopes for the user fee conference.

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