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.’
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Acting OGD Director Susan Rosencrance says in an interview that the generics assessment system has evolved substantially since she moved to the Office of Pharmaceutical Quality in 2015.
Sponsors looking to file applications continue to wait for the new user fees to be announced, as details of the Split Real-Time Application Review (STAR) program, generic drug facility inspection readiness requirement and other changes are revealed.
The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.