GDUFA Research Outcomes
Nasal Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the nasal route, including nasal sprays.
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Scientific Careers at FDA: Where Science Meets Regulations and Public Health
Bielski, Elizabeth
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Advancements in In Vitro Studies for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies
Bielski, Elizabeth
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Clinically Relevant In Vitro Tests for the Assessment of Innovator and Generic Nasal Spray Products
Azimi, Mandana; Longest, P Worth; Shur, Jag; Price, Robert; Hindle, Michael