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  5. Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019 - 09/25/2019 - 09/26/2019
  1. CDER Small Business & Industry Assistance (SBIA)

Workshop

Event Title
Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019
September 25 - 26, 2019

Scheduled

Date:
September 25 - 26, 2019
Time:
8:30 AM - 5:10 PM ET
Location:
Event Location
The Hotel
at the University of Maryland

7777 Baltimore Ave.
College Park, MD 20740
United States


Speaker(s):
Sally Choe, Ph.D.
Leadership Role
Director - Office of Generic Drugs

Organized By:

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View Slides

Session Speaker
Keynote with Sally Choe Sally Choe, Ph.D.
Director of the Office of Generic Drugs
Pre-ANDA Program Update Karen Bengtson
Office of Research and Standards (ORS) Office of Generic Drugs (OGD) | CDER
Suneela Prodduturi
Office of Pharmaceutical Quality (OPQ) | CDER
FDA’s Inactive Ingredient Database Susan Zuk
Office of Policy for Pharmaceutical Quality (OPPQ) | OPQ | CDER
Panel Discussion Karen Bengtson, Suneela Prodduturi, Susan Zuk, Kris André (ORS | OGD), Robert Lionberger (ORS | OGD), Jonathan Hughes (Office of Generic Drug Products (OGDP) | OGD)
Generic Topical and Transdermal Products Sam Raney
ORS | OGD | CDER
Bioequivalence for Generic Topical and Transdermal Priyanka Ghosh ORS | OGD | CDER
Strategies for Generic Topical Product Development Tannaz Ramezanli ORS | OGD | CDER
Quality for Transdermal Delivery Systems Brock Roughton
Office of Lifecycle Drug Products (OLDP) | OPQ | CDER
Questions and Answers Sam Raney, Priyanka Ghosh, Tannaz Ramezanli, Brock Roughton
Strategies to Demonstrate Complex API Sameness Deyi Zhang
ORS | OGD | CDER
Complex Peptide ANDAs: Test/Reference Comparability Cameron Smith
OLDP | OPQ | CDER
Considerations of Particle Analysis Xiaoming Xu
Office of Testing and Research (OTR) | OPQ | CDER
Questions and Answers Deyi Zhang, Cameron Smith, Xiaoming Xu, Ram Randad (ONDP | OPQ), Darby Kozak (ORS |OGD)
BE Approaches for Long Acting Drug Products Yan Wang
ORS | OGD | CDER
Strategies to Demonstrate Complex Excipient Sameness Bin Qin
ORS | OGD | CDER
In Vitro Drug Release Testing for LA Drug Products QC Vidula Kolhatkar
Office of New Drug Products (ONDP) | OPQ | CDER
Questions and Answers Yan Wang, Bin Qin, Vidula Kolhatkar, Bing Cai (OLDP | OPQ)
What Constitutes Complex Drug-Device Combination Lisa Bercu
OGDP | OGD | CDER
Overview of Comparative Analyses - Clinical Perspective Michelle Lin
Office of Bioequivalence (OB) | OGD | CDER
Quality View on Injectable Product Considerations Bita Mirzai Azarm
OLDP | OPQ | CDER
Comparative Analyses: Injectable Combination Products Andrew Fine
OB | OGD | CDER
Questions and Answers Lisa Bercu, Bing Cai, Kimberly Witzmann (OB | OGD), Steven Hertz (Office of Process and Facilities (OPF) | OPQ), Alan Stevens (Center for Devices and Radiological Health (CDRH)
PSG Recommendations and Updates for OINDPs Bryan Newman
ORS | OGD | CDER
Pre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs Denise Conti
ORS | OGD | CDER
Comparative Analyses: Device and User Interface Kimberly Witzmann
ORS | OGD | CDER
BE for Bridging Studies with Orally Inhaled/Nasal Drugs Tian Ma
OB | OGD | CDER
CMC Updates for Orally Inhaled Drugs Fang Yuan
OLDP | OPQ | CDER
Questions and Answers Bryan Newman, Denise Conti, Kimberly Witzmann, Tian Ma, Fang Yuan, Bhagwant Rege (OLDP | OPQ)
Quantitative Methods and Modeling Liang Zhao
ORS | OGD | CDER
PK/PD Meta-analysis of Abuse Deterrent Opioid Drugs Lanyan (Lucy) Fang
ORS | OGD | CDER
Dose-Scale Analysis in Pharmacodynamic Equivalence Xiajing Gong
ORS | OGD | CDER
Physiologically-based Pharmacokinetic Modeling Eleftheria Tsakalozou
ORS | OGD | CDER
Credibility for Computational Fluid Dynamics Models Ross Walenga
ORS | OGD | CDER
Quantitative Clinical Pharmacology in LA Injectables Satish Sharan
ORS | OGD | CDER
Panel Questions and Discussion Liang Zhao, Yaning Wang (OCP | OTS), Robert Lionberger (ORS | OGD), Murray Ducharme (Learn and Confirm, Inc.)

About

As a continuation from the 2018 workshop on complex generic drug products, the goal of this science-focused workshop is to communicate to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. FDA will link GDUFA science and research on complex drug products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine various areas of complex product science.

Complex drug products often have features that make them harder to develop as generics under traditional approaches. These challenges can mean these ANDAs may undergo more assessment cycles than other ANDAs for non-complex generic drug products before receiving FDA approval, which, in turn, may result in limited competition. That is why the FDA has made facilitating the development and approval of complex generic drug products a major focus of the FDA’s Drug Competition Action Plan, which is aimed at encouraging generic drug competition in an effort to help reduce drug prices. It is our hope that the Complex Generic Drug Product Development Workshop will help facilitate the development and approval of ANDAs for complex generic drug products and the introduction of more generic medicines to the complex drug marketplace.

Topics Covered

  • Pre-ANDA program update
  • FDA’s inactive ingredient database: improvements on the path to 2020
  • Scientific and regulatory advances for generic topical and transdermal drug product development
  • Characterization of complex injectable active pharmaceutical ingredient API and formulations
  • Bioequivalence approaches for complex injectable API and formulations
  • Complex drug-device combination products – injectable drug products
  • Complex drug-device combination products – orally-inhaled and nasal drug products
  • Quantitative methods and modeling-informed regulatory decision making

Intended Audience

Scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of complex generic drugs.

Learning Objectives

After this workshop, participants will be able to:

  • Explain various mechanisms and processes that industry can use to obtain advice from the FDA to facilitate complex generic drug product development; and
  • Summarize new developments in science, guidance, and review experience for specific types of complex generic drug products.

FDA Resources


Contact

Event Contact
CDER Small Business and Industry Assistance
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
(866) 405-5367
CDERSBIA@fda.hhs.gov
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