ANDA Sponsors Need To 'Slow Down' And Focus On Quality, US FDA Generics Director Says
Kathleen Uhl says applicants can avoid RTRs by conducting quality checks before submission, but sponsors may have difficulty changing their approach because of how fundamental application speed is to their business model.
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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.
Both issues have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.
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.