FDA And Industry Set Out GDUFA III Priorities
Focusing Initially On First-Cycle Approvals And Priority Assessment Improvements
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.
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Complex Generics: Pre-Competitive Research Collaborations To Get US FDA Funding Boost
Center for Research on Complex Generics will be similar to the Critical Path Institute; training sessions for industry could begin in January.
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.
Will GDUFA III Curtail Priority Assessments?
US FDA's expedited pathway for generics seems to provide more benefits for amendments than for original ANDAs.