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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Next US FDA Generics Leader Must Have ‘Frank Conversations’ With Colleagues, Industry, Former OGD Director Says
Susan Rosencrance, who helped negotiate GDUFA III, will take over as acting director of the Office of Generic Drugs following Sally Choe’s departure on 8 October. Former OGD head Uhl says the director needs to be the ‘number one advocate for the generic drug program inside the agency.’
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.