FDA News: Issue 6-1, June 2024

Author: [AUTHOR] Published on 6/7/2024 12:00:00 AM

FDA’s SBIA Webinar on Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice

On June 13, 2024, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) will host a webinar entitled OSIS Workshop: CDER Bioavailability/Bioequivalence (BA/BE) Study Sites and Inspections of Good Laboratory Practice. In this event, FDA experts will describe the Mission and Vision of the Office of Study Integrity and Surveillance (OSIS), discuss the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection, provide an overview of compliance programs dealing with inspections of facilities that perform Good Laboratory Practice, Animal Rule, In Vivo Clinical BA/BE, and In Vivo Analytical BA/BE studies, and engage attendees to work through case studies representative of the above programs. 

Topics Covered:

  • Expectations during BA/BE Inspections – Immunogenicity, Clinical, Clinical Endpoints and Analytical Clinical Programs
  • Overview of Good Laboratory Practice/Animal Rule Compliance Programs and inspections
  • Understanding of the OSIS BA/BE Program that includes BA Studies 505b2, BE studies, In Vitro BE studies and immunogenicity studies
  • Gain a better understanding of reserve sample requirements

June 13, 2024
8:50 AM - 11:25 AM ET

Additional Details:
Attendance is virtual, and continuing education credits are available. The webinar is free, but registration is required. For more information on this webinar, including specific topics to be covered, agenda, and intended audience, please visit the meeting website.

CDER’s SBIA aims to help small pharmaceutical business and industry navigate the wealth of information that FDA offers and assist in understanding human drug product regulation. To learn more about CDER’s SBIA, visit their website.



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We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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