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Thursday, June 28 • 9:00am - 10:15am
#412: Metrics and Meaning: Evolving Metrics in Generic Drug Application Review and Communications to Improve ANDA Submission Planning and Approvability

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-694-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Generic Drug User Fee Amendments of 2012 (GDUFA I) brought substantial change to the USFDA’s generic drug application (known as the abbreviated new drug application or “ANDA”) review program. GDUFA I created agency goals related to timelines for the agency completing reviews of generic drug original applications, prior approval supplements and amendments to both. These metrics helped to initiate changes and process improvements.
The agency continues to develop an enhanced process and tracking information system, along with additional performance reports. The inclusion of more informative measures of performance of the agency and sponsors in moving applications towards approvability may provide better understanding of critical attributes and parameters in the communications between the agency and sponsors. Improving these communications will allow FDA to move ANDAs to approvability in a timelier manner.
This session will introduce metrics and analyses FDA is developing for improving the communication of and response to critical attributes and deficiencies in original ANDA submissions and in their review and development path to approval. Presentations will describe current efforts to identify and track ANDA review attributes and communication qualities that inhibit or enhance sponsors’ effective responses to address ANDA deficiencies.

Learning Objectives

Discuss the metrics and analysis used by FDA to review ANDAs and improve the overall approval process; Discuss the impact of improved communications, tracking, and measures of performance on the submission and approval timeline.

Chair

Jason Woo, MD, MPH

Speaker

FDA Update
Rong (Gloria) Fu, PhD

Abbreviated New Drug Application (ANDA) First Cycle Approvability: A GDUFA I Preliminary Report
Jingyu (Julia) Luan, PhD

FDA Update
Geoffrey Wu, PhD


Speakers
RG

Rong (Gloria) Fu

Commissioners Fellow, OGD, CDER, FDA
Dr. Fu currently is a staff fellow in CDER/FDA. Previously, she had over 8 years of R&D experience across academia and industry in developing nanomedical products. Her expertise includes designing novel nanomaterials for drug formulations and medical devices, transferring processes... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Deputy Division Director (Acting), OB, OTS, CDER, FDA
Jingyu (Julia) Luan joined the FDA CDER in 2006. She was a reviewer in Division of Biometrics I, and in 2014 she was selected as a Team Leader in Division of Biometrics VIII. Before the FDA, she was a research faculty at Johns Hopkins University and a statistical consultant at University... Read More →
avatar for Jason Woo

Jason Woo

Senior Medical Officer, Office of Generic Drugs, CDER, FDA
CAPT Jason Woo, M.D., M.P.H., FACOG, has held clinical and administrative positions with the Indian Health Service (IHS), and the NIH/NICHD. Dr. Woo’s his work with the FDA includes as a Clinical Evaluation Team Leader in and as the Associate Director for Scientific and Medical... Read More →
avatar for Geoffrey Wu

Geoffrey Wu

Associate Director for Science and Communication, OLDP, OPQ, CDER, FDA, FDA
Geoffrey Wu is a scientist officer in the United States Public Health Service. He is the Associate Director for Science & Communication in Office of Lifecycle Drug Products (OLDP), OPQ. He has been (co)leading quality assessment and research in controlled correspondence, ANDAs, supplemental... Read More →

Thursday June 28, 2018 9:00am - 10:15am
Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session