Learning Tracks

GDUFA III calls for new enhancements to the program designed to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles for abbreviated new drug applications (ANDAs) and facilitate timely access to quality, affordable, safe and effective generic medicines. In this session, both FDA and industry will share perspectives on best practices for reducing the number of review cycles for DMFs and ANDAs, how to better coordinate between the DMF and ANDA reviews, and the role of Controlled Correspondence.

Moderator: Giuseppe Randazzo
Vice President, Sciences and Regulatory Affairs, AAM

Speakers:
Aparna Dagar, PhD, RAC
Senior Director, Regulatory Affairs, Fresenius Kabi USA

CAPT Robert Gaines, PharmD 
Deputy Director, Office of Program and Regulatory Operations (OPRO), OPQ, CDER, FDA

CDR Chitra Mahadevan, PharmD, MS, BCPS, PMP
Director, Division of Bioequivalence Process Management, Office of Bioequivalence (OB), OGD, CDER, FDA

Rajeev Mathur
Senior Vice President and Head Global Regulatory Affairs, Sun Pharma

Panelists:

LCDR Malik Imam, PharmD
Deputy Director, ORO, OGD

Jennifer Miller, PhD
Deputy Director, Office of Bioequivalence (OB), OGD, CDER, FDA