Workshop
Event Title
Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019
September 25 - 26, 2019
- Date:
- September 25 - 26, 2019
- Location:
-
Event LocationThe Hotel
at the University of Maryland
7777 Baltimore Ave.
College Park, MD 20740
United States
- Speaker(s):
-
Sally Choe, Ph.D.
Leadership RoleDirector - Office of Generic Drugs
- Organized By:
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
- Generic Drug Science and Research
- Guidance for Industry, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
- Draft Guidance for Industry, Controlled Correspondence Related to Generic Drug Development
- Draft Guidance for Industry, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA
- Product-Specific Guidances for Generic Drug Development
- Upcoming Product-Specific Guidances for Complex Generic Drug Product Development
- Draft Guidance for Industry, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - Quality Considerations
- Guidance for Industry, Safety Considerations for Product Design to Minimize Medication Errors
Contact
- CDER Small Business and Industry Assistance
-
CDER Small Business and Industry Assistance
Division of Drug Information
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
- (866) 405-5367
- CDERSBIA@fda.hhs.gov