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| Name | A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs |
| Video Uploader | Video From U.S. Food and Drug Administration |
| Upload Date | This Video Uploaded At 22-01-2024 14:41:06 |
| Video Discription | FDA further discusses the MIE meeting pilot program, which addressed the considerations and expectations when meeting with FDA under the Industry Meeting Pilot MIE Program and discussed the types of potential topics that will be granted under the pilot program. Timestamps 06:18 – Introduction 18:28 – Process Overview 34:00 – Potential Topics for Discussion Through the MIE Industry Meeting Pilot Program 47:15 – Consideration and Expectations When Meeting with the FDA Under the Industry Meeting Pilot Program 01:02:27 – Speaker Panel Discussion 01:32:03 – Q&A Discussion Panel 01:56:51 – Closing Remarks Speakers | Panelists: Liang Zhao, PhD Director Division of Quantitative Methods and Modeling (DQMM) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) CDER | US FDA Maria Monroy-Osorio Regulatory Health Project Manager ORS | OGD | CDER | US FDA Andrew Babiskin, PhD Lead Pharmacokineticist DQMM | ORS | OGD | CDER | US FDA Eleftheria Tsakalozou, PhD Senior Pharmacologist (Acting TL) DQMM | ORS | OGD | CDER | US FDA Lanyan (Lucy) Fang, PhD Deputy Director DQMM | ORS | OGD | CDER | US FDA Bhagwant Rege, PhD Division Director Division of Biopharmaceutics (DB) Office of New Drugs (NDP) Office of Pharmaceutical Quality (OPQ) CDER | US FDA Partha Roy, PhD Director Office of Bioequivalence (OB) OGD | CDER | US FDA Robert Lionberger, PhD Director ORS | OGD | CDER | US FDA Fang Wu, PhD Senior Pharmacologist DQMM | ORS | OGD | CDER | US FDA Meng Hu, PhD Lead Engineer DQMM | ORS | OGD | CDER | US FDA Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/deep-dive-fdas-model-integrated-evidence-mie-industry-meeting-pilot-program-generic-drugs-01182024 ----------------------- 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/accounts/USFDA/subscriber/new?topic_id=USFDA_352 SBIA 2022 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-UxcxbzCGn90m38cXN2DL2i3VmD SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - https://twitter.com/FDA_Drug_Info Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367 |
| Category | Science & Technology |
| Tags | FDA | CDER | SBIA | Model-Integrated Evidence | MIE | Pilot Program | Industry | Meeting | Program | Process Overview | Considerations | Expectations |
