ANDA Approval Records Will End As US FDA Mops Up Backlog
CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
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FDA And Industry Set Out GDUFA III Priorities
Both first-cycle approvals and priority assessment improvements have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.
GDUFA III: First-Cycle Approval, Priority Assessment Improvements Are Early Priorities
Both issues have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.
Woodcock's Prophesy Comes True: US FDA ANDA Approvals Decline From Record Levels
Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.