A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs

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...

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