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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FDA decided against trying to predict upcoming approvals as part of FY 2019 GDUFA program fee calculations, but other adjustments likely increased fee significantly.
Office of Generic Drugs Director Kathleen Uhl calls a two-cycle approval timeline a realistic expectation for ANDA approval, but would not say that most ANDAs will fall into the paradigm.
Generic applications continue to be tripped up by failing to adhere to other well-known standards such as paying user fees, US agency says.