Learning Tracks

In this session, FDA will share trends and learnings related to common deficiencies seen in original ANDAs and supplements. Panelists will provide feedback on what constitutes a quality submission, including what’s needed for filing consideration with respect to complex products, combination products, RLD labeling, and other areas that have historically proven challenging.

Participants:
Yanira Gonzalez-Berrios, PhD
Senior Chemist, Division of Product Quality Assessment VII (DPQAVII), Office of Product Quality Assessment II (OPQAII), OPQ, CDER, FDA

Martin Shimer, II, RPh
Executive Director, Lachman Consultant Services, Inc.

Houri Simonian-Houldsworth, PhD
Senior Director, Analytical Research & Development, Apotex Inc.

Xiaojian Jiang, PhD
Deputy Division Director, Division of Bioequivalence II (DBII), OB, OGD,CDER, FDA

Johnny Young
Director, Division of Filing Review, Office of Regulatory, OGD, CDER, FDA

Moderator: Meenakshi Jain, MPharm
Senior Director, Regulatory Generics Development, Sandoz