PDUFA VII Commitment Letter Outlines Real-Time Review Expansion, Hiring Goals
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
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Lola Fashoyin-Aje, formerly associate director of the Oncology Center of Excellence, will become director of the CBER Office of Therapeutic Products’ Office of Clinical Evaluation.
The program bringing Operation Warp Speed-like treatment to rare disease product development could expand if successful, but will require more employees and thus funding commitments from Congress and industry, CBER Director Peter Marks said.
Julie Tierney will become CBER’s deputy director for strategy, policy and legislation, a newly created position.