Webcast | Virtual
Event Title
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
February 24, 2022
- Date:
- February 24, 2022
- Time:
- 1:00 PM - 3:00 PM ET
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ABOUT THIS WEBINAR
In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s recommendations regarding BE information submitted in an Abbreviated New Drug Application (ANDA) submission, provide assistance to potential ANDA applicants, and support access for patients to lower cost, high quality medicines.
This webinar will take a deeper look at the revised draft guidance, describe major changes from the previous draft guidance published in 2013, and provide clarification to comments received through the public docket. For example, we received questions on study population (with regard to sex and age), and bioequivalence assessment for additional strengths of modified-release products.
LEARNING OBJECTIVES
- Provide an overview of the revised drug guidance
- Describe the major changes in the revised draft guidance
- Provide clarification and rationale on selected topics to address comments received
- Understand how principles described in the revised draft guidance in conjunction with product-specific guidances and other pre-submission communications facilitate generic drug development and generic drug application assessment
INTENDED AUDIENCE
- Generic drug industry, including current and potential applicants who are interested in submitting an application for generic drugs
- Regulatory reviewers and policy makers for generic drug development and assessments
FDA SPEAKERS
Lei Zhang, PhD, Deputy Director, Office of Research and Standards (ORS), Office of Generic Drugs (OGD) | CDER
Nilufer Tampal, PhD, Associate Director of Scientific Quality, Office of Bioequivalence (OB) | OGD | CDER
FDA PANELISTS
David Coppersmith, Regulatory Counsel, Office of Generic Drug Policy (OGDP) | OGD
Myong-Jin Kim, PharmD, Division Director, Division of Therapeutic Performance II (DTP II) | ORS | OGD
Bing Li, PhD, Associate Director for Science, OB | OGD
Robert Lionberger, PhD, Director, ORS | OGD
Diana Vivian, Acting Associate Director, Division of Bioequivalence II (DBII) | OB | OGD
Liang Zhao, PhD, Division Director, Division of Quantitative Methods and Modeling (DQMM) | ORS | OGD
FDA RESOURCES
- Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
- Bioequivalence Recommendations for Specific Products
- Product-Specific Guidances for Generic Drug Development (main page)
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
Event Materials
| Title | File Type/Size |
|---|---|
| Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA_February 24, 2022 | pdf (1.39 MB) |