Best Practices for Topical Generic Product Development and ANDA Submission August 11, 2022

Virtual | Virtual

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• Date: August 11, 2022
• Time: 9:30 AM - 12:30 PM ET

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Topics & Presentations	Speakers
Best Practices for Topical Generic Product Development and ANDA Submission–Introduction & Session 1
Introduction to the Webinar	Priyanka Ghosh, PhD Acting Team Lead DTP-I | ORS | OGD | FDA
Scientific and Regulatory Considerations for Q3 Characterization of Topical Products	Sam Raney, PhD Associate Director for Science ORS | OGD | FDA
Q&A Panel on Q3 Characterization of Topical Products	Moderator: Priyanka Ghosh, PhD Acting Team Lead DTP-I | ORS | OGD | FDA Rob Lionberger, PhD Director ORS | OGD | FDA Markham Luke, MD, PhD Director DTP-I | ORS | OGD | FDA Pahala Simamora, PhD Director DLBP-II | OLDP | OPQ | FDA Sam Raney, PhD Associate Director for Science ORS | OGD | FDA
Best Practices for Topical Generic Product Development and ANDA Submission – Session 2
Practical Considerations for IVRT Studies with Topical Products Submitted in ANDAs	Tannaz Ramezanli, PhD Pharmacologist DTP-I | ORS | OGD | FDA
Q&A Panel on IVRT Studies with Topical Products	Moderator: Priyanka Ghosh, PhD Acting Team Lead DTP-I | ORS | OGD | FDA Xiran Li, PhD Staff Fellow DB-II | OB | OGD | FDA Anil Nair, PhD Team Leader DB-II | OB | OGD | FDA Hiren Patel, PhD Staff Fellow DB-II | OB | OGD | FDA Tannaz Ramezanli, PhD Pharmacologist DTP-I | ORS | OGD | FDA Sam Raney, PhD Associate Director for Science ORS | OGD | FDA
Best Practices for Topical Generic Product Development & ANDA Submission–Session 3, Closing Remarks
Practical Considerations Related to IVPT Studies for Topical Products Submitted in ANDAs	Hiren Patel, PhD Staff Fellow DB-II | OB | OGD | FDA
Q&A Panel on IVPT Studies with Topical Products	Moderator: Priyanka Ghosh, PhD Acting Team Lead DTP-I | ORS | OGD | FDA Usha Katragadda, PhD Staff Fellow DB-II | OB | OGD | FDA Archana Manerikar, MS, PharmD Pharmacologist DB-I | OB | OGD | FDA Hiren Patel, PhD Staff Fellow DB-II | OB | OGD | FDA Sam Raney, PhD Associate Director for Science ORS | OGD | FDA Elena Rantou, PhD Lead Mathematical Statistician DB-VIII | OB* | OTS | FDA
Closing Remarks	Priyanka Ghosh, PhD Acting Team Lead DTP-I | ORS | OGD | FDA

Agenda

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ABOUT THIS WEBINAR

In vitro studies that can support a demonstration of bioequivalence (BE) for topical generics typically include comparative physicochemical and structural (Q3) product characterization tests as well as in vitro release test (IVRT) and in vitro permeation test (IVPT) studies.

This webinar will provide an overview of comparative Q3 characterization as well as IVRT and IVPT studies for topical generic drug product development and common deficiencies FDA has encountered in these studies. This webinar will highlight best practices and resources that FDA has developed and made publicly available to help generic drug applicants successfully implement efficient in vitro characterization-based BE approaches for topical generic products.

There will be live question and answer sessions dedicated to each of three topic areas where audience can interact directly with FDA experts to help clarify questions and help generic drug applicants overcome challenges with developing topical generic products or preparing abbreviated new drug applications for these products.

LEARNING OBJECTIVES

• Explain the rationale and clarify practical considerations for conducting Q3 characterization tests for topical drug products submitted in ANDAs
• Explain the rationale and clarify practical considerations for conducting IVRT studies for topical drug products submitted in ANDAs
• Explain the rationale and clarify practical considerations for conducting IVPT studies for topical drug products submitted in ANDAs

INTENDED AUDIENCE

• Generic drug industry, including current and potential generic drugs applicants

FDA RESOURCES

• Product-Specific Guidances for Generic Drug Development
• FDA Drug Competition Action Plan
• Public Workshop: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions

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Event Materials

Title	File Type/Size
Practical Considerations for IVRT Studies with Topical Drug Products Submitted in ANDAs August 11, 2022	pdf (826.00 KB)
Practical Considerations Related to In-vitro Permeation Test Studies for Topical Products Submitted in ANDAs August 11, 2022	pdf (1.96 MB)
Scientific and Regulatory Considerations for Q3 Characterization of Topical Products August 11, 2022	pdf (436.30 KB)