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Complex Generics: Nasal and Inhalation Products

FDA discusses topics in complex generic nasal and inhalation products. Includes responses to audience in a question-and-answer panel. Presenters and presentations include:

Product-Specific Considerations for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies
Susan Boc, PhD; DTP I|ORS|OGD|CDER

Approaches for studies interrupted due to COVID-19 for Nasal and Inhalation Products
Vipra Kundoor, PhD; DB I|OB|OGD|CDER

Demonstrating Bioequivalence with Inhalation Spray Drug Products
Sneha Dhapare, PhD; DTP I|ORS|OGD|CDER

Comparative Analyses for Generic Oral Inhalers
Michael Spagnola, MD; DCSS|OSCE|OGD|CDER

Q&A Panel (Including all above presenters):
Bryan Newman, PhD; DTP I|ORS|OGD|CDER
Changning Guo, PhD; DCDA|OTR|OPQ|CDER
Bing Cai, PhD; DLBP I|OLPD|OPQ|CDER
For slides and additional information: https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-translating-science-approval-09212021-09222021
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