US FDA Generic Approvals Break 900 Barrier In FY 2019
Executive Summary
The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.
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FDA Generic Approvals Peak In April
The April total is the highest monthly total in seven months, but only a few are first generics. Approval volume might continue rising if FDA does not find too many applications requiring in-person inspections, which were largely postponed as part of coronavirus containment measures, Robert Pollock, senior advisor and outside director to the board at Lachman Consultants, said.