Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 1 скачать в хорошем качестве

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 1

FDA experts demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in ANDAs alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA and ANDA meeting discussions. Timestamps 01:09 – Teriparatide Injection First Generic Approval: Quality-Related Review Considerations 18:33 – Quality Considerations for First Generic Oral Solutions 40:29 – Quality Considerations for First Generic Tiotropium Bromide Capsule-Based Dry Powder Inhalers (DPIs) 01:03:44 – Session 5A: Q&A Panel Session Leads: Sheela Rajesh, PhD Senior Pharmaceutical Quality Assessor Division of Product Quality Assessment IX (DPQA IX) Office of Product Quality Assessment II (OPQA II) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) Eric Pang, PhD Senior Chemist Division of Therapeutic Performance I (DTP I) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) | CDER Speakers | Panelists: Tina Jiao, MS Chemist Division of Product Quality Assessment IV (DPQA IV) Office of Product Quality Assessment (OPQA) OPQ | CDER Maria Flynn, PhD Senior Pharmaceutical Quality Assessor Division of Product Quality Assessment VIII (DPQA VIII) OPQA II | OPQ | CDER Nashwa El-Gendy, PhD Senior Pharmaceutical Quality Assessor Division of Product Quality Assessment V (DPQA V) Office of Product Quality Assessment I (OPQA I) OPQ | CDER Yili Li, PhD Senior Pharmaceutical Quality Assessor Division of Product Quality Assessment XI (DPQA XI) OPQA II | OPQ | CDER Bryan Newman, PhD Lead Pharmacologist DTP I | ORS | OGD | CDER Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367