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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OTAT Director Bryan, who has worked at the FDA for more than 20 years, will depart by the end of March as the agency’s cell and gene therapy operations are poised for a major overhaul and a large number of new hires.
US FDA Neurology Drugs Program Gains Boost In FY 2023 Funding Bill Amid Calls To Clarify Development Policies
US FDA gains a nearly 7% increase in non-user fee funding, some of which will go for neurology drug guidance.
Advocates also worry that long follow-up times could prevent participation in future clinical trials.