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Tuesday, June 26 • 10:30am - 11:45am
#239: Generic Drug Town Hall

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will include information related to the implementation, policy, and regulatory science updates related to the Generic Drug User Fee Amendments (GDUFA).

Learning Objectives

Recognize challenges inherent to implementing the Generic Drug User Fee Amendments (GDUFA); Discuss policies impacting generic drug development, regulatory review, oversight, inspections and facilities assessments; Describe an update on regulatory science initiatives for complex generic drug products; Discuss opportunities for industry to move toward improved generic application approvability, related to the FDA Commissioner’s actions to improve access to affordable medicines.

Chair

Kathleen Uhl, MD

Speaker

Panelist
Maryll Toufanian, JD

Panelist
Robert A. Lionberger, PhD

Panelist
Susan M. Rosencrance, PhD

Panelist
Ashley Boam, MS

Panelist
Alonza Cruse



Speakers
avatar for Ashley Boam

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies & standards related to drug product quality, including... Read More →
avatar for Alonza Cruse

Alonza Cruse

Director, Office of Pharmaceutical Quality Operations, ORA, OGROP, FDA
Director, Office of Pharmaceutical Quality Operations within FDA’s Office of Regulatory Affairs (ORA), responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic, working in conjunction with FDA Centers: CDER and CVM. Alonza is also leading... Read More →
avatar for Robert Lionberger

Robert Lionberger

Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA
Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants... Read More →
avatar for Susan Rosencrance

Susan Rosencrance

Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Dr. Susan Rosencrance currently serves as the Director for the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality (OPQ). In this capacity, she directs procedures and processes for evaluating and assessing drug product quality of both brand name and generic drug... Read More →
avatar for Maryll Toufanian

Maryll Toufanian

Director, FDA Office of Generic Drug Policy, FDA
Maryll W. Toufanian, J.D., serves as Acting Director of FDA’s Office of Generic Drug Policy (OGDP), which provides oversight and direction in the development of policies concerning all aspects of generic drugs, and advises the generic drug program on application-specific policy... Read More →
avatar for Kathleen Uhl

Kathleen Uhl

Director, Office of Generic Drugs, CDER, FDA
Kathleen Uhl, MD currently serves as the Director for the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). This office is responsible for the review and approval of Abbreviated New Drug Applications (ANDAs) and... Read More →


Tuesday June 26, 2018 10:30am - 11:45am
Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA