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FDA official highlights steady generic approvals, first-generics and rising review activity
Summary
Darby Kozak, deputy director of the FDA Office of Generic Drugs, summarized program performance, citing hundreds of recent ANDA actions, dozens of first-generic approvals and increased overall FDA drug actions over five years, and previewed initiatives to reduce delays and improve transparency.
Darby Kozak, deputy director of the FDA Office of Generic Drugs, opened the Generic Drug Forum with an overview of program performance and priorities to expand patient access to affordable medications. Kozak said the office approved or tentatively approved a substantial volume of ANDAs in the most recent fiscal year, including 92 first generics and about 125 complex generics, and reported continued momentum into the next fiscal year.
Kozak framed the activity as part of a broader increase in regulatory review work, saying total FDA drug actions rose from about 9,500 in fiscal 2020 to more than 11,000 in fiscal 2025. She emphasized practical steps applicants can take to avoid delays—"including this information supports that the application is being substantially complete and ready for filing"—and pointed attendees to OGD's consolidated online resources to improve submission quality.
