Learning Tracks

Common Deficiencies for ANDAs and Supplements

Wednesday, October 4, 2023

10:00 a.m. - 11:30 a.m.

In this session, FDA will share trends and learnings related to common deficiencies seen in original ANDAs and supplements. Presenters also will provide feedback on the quality of submissions, including information on combination products, complex products, RLD labeling changes, and other challenging areas.

Speakers:

Sandra Bai, PharmD
Labeling Reviewer, Division of Labeling Review, ORO, OGD, CDER, FDA

Yafei Jin, MS
Chemist, Division of Liquid-Based Products II, OLDP, OPQ, CDER, FDA

Rajeev Mathur
Head – Global Regulatory & Business Continuity, Sun Pharma

Charlene Peterson, PharmD
Labeling Reviewer, Division of Labeling Review, ORO, OGD, CDER, FDA

Alberto Rivalta, M.S.
Senior Director, Generics Regulatory Affairs, Teva Pharmaceuticals USA

Hongfei Zhou, PhD
Pharmacologist, Division of Bioequivalence III, OB, OGD, CDER, FDA

Panelists:

April Braddy, PhD
Division Director, Division of Bioequivalence III, OB, OGD, CDER, FDA

Oluwakemi (Kemi) Odesina, PharmD, BCPS, CPH
Labeling Reviewer, Division of Labeling Review, ORO, OGD, CDER, FDA