Model Master Files: Advancing Modeling/Simulation in Generic Drug Development/Regulatory Submissions скачать в хорошем качестве

Model Master Files: Advancing Modeling/Simulation in Generic Drug Development/Regulatory Submissions

This event provided an update on FDA’s efforts related to Model Master Files (MMFs). The agenda included presentations by FDA staff that will focus on an introduction and overview of MMFs, considerations for developing and submitting MMFs to support ANDAs using a Type V DMF, and a cross-comparison to other types of DMFs, including lessons learned. Timestamps 00:55 – Introduction and Overview of the Model Master File 11:22 – Model Master File: How to Develop and Submit One? 33:13 – Cross-comparison to Other Drug Master Files and Lessons Learned Speakers: Lanyan (Lucy) Fang, PhD Deputy Division Director Division of Quantitative Methods and Modeling (DQMM) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) | CDER Eleftheria Tsakalozou, PhD Lead Pharmacologist DQMM | ORS | OGD | CDER Erin Skoda, PhD Supervisory Chemist Division of Product Quality Assessment XVIII (DPQA XVIII) Office of Product Quality Assessment III (OPQA III) Office of Pharmaceutical Quality (OPQ) 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 2025 Playlist -    • 2025 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 - [email protected] Phone - (301) 796-6707 I (866) 405-5367