SBIA Webinar | Registration open for BE Studies with PK Endpoints for Drugs Submitted Under an ANDA

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Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA February 24, 2022 1:00 PM - 3:00 PM ET Register ABOUT THIS WEBINAR In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency's recommendations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 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 This webinar will take a deeper look at the revised draft guidance, describe major changes from the previous draft guidance published in 2013, and provide clarification to comments received through the public docket.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. TOPICS Provide an overview of the revised drug guidance Describe the major changes in the revised draft guidance Provide clarification and rationale on selected topics to address comments received Understand how principles described in the revised draft guidance in conjunction with product-specific guidances and other pre-submission communications facilitate generic drug development and generic drug application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 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) 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 ORS | Office of Generic Drugs (OGD) | CDER Nilufer Tampal, PhD Associate Director of Scientific Quality OB | OGD | CDER FDA PANELISTS: David Coppersmith Regulatory Counsel, OGDP | OGD Myong-Jin Kim, PharmD, Division Director, DTP II | ORS | OGD Bing Li, PhD, Associate Director for Science, OB | OGD Robert Lionberger, PhD, Director, ORS | OGD Diana Vivian, Acting Associate Director, DB II | OB | OGD Liang Zhao, PhD, Division Director, DQMM | ORS | OGD 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: 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. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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