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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In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s recommendations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This webinar will take a deeper look at the revised draft guidance, describe major changes from the previous draft guidance published in 2013, and provide clarification to comments received through the public docket.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• Describe the major changes in the revised draft guidance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• Understand how principles described in the revised draft guidance in conjunction with product-specific guidances and other pre-submission communications facilitate generic drug development and generic drug application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)

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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