The FDA publishes guidance documents to aid the medical products industry and the public in understanding and applying the regulations and requirements for pharmaceutical and medical device marketing approval. Supplemental information (in the form of Q&A guidance, web pages, webinars, and other materials) is also available to help clarify particular guidance when necessary, and CDER’s Small Business and Industry Assistance plays an active role in creating and distributing this additional information. On June 17, 2019, SBIA hosted a particularly rich session on bioanalytical method validation which is now available for free at the SBIA website. Consisting of 4 sessions, this on-demand webinar discusses the bioanalytical method validation guidance issued in May 2018 and covers:

• What’s new in the guidance for NDAs and BLAs – presented by Brian Booth, Deputy Director in the Division of Clinical Pharmacology;
• Method validation in the context of ANDAs – presented by Leah Falade, Lead Pharmacologist, and Suman Dandamundi, Staff Fellow, of the Office of Bioequvalence in the Office of Generic Drugs;
• Inspections of Bioanalytical/Bioequivalence Studies – presented by Seongeun Julia Cho, Director, and John Kadavil, Deputy Director of the Division of Generic Drug Bioequivalence Evaluation Office of Study Integrity and Surveillance; and 
• Current thinking on accuracy and precision in bioanalysis – presented by Charles Bonapace, Director, and Arindam Dasgupta, Deputy Director of the Division of New Drug Bioequivalence Evaluation, Office of Study Integrity and Surveillance

The webinar series includes both recordings and slides and covers a wide variety of topics that practitioners will want to understand. Some examples include new recommendations for validation of new diagnostics and biomarkers and use of new analytical technology for NDAs and BLAs, how assessors of ANDAs review bioanalytical methods in applications, the inspection process relating to bioanalytical methods, and a review of the guidance recommendations on accuracy and precision in bioanalytical methods. In my opinion this webinar series would be excellent (and free) continuing education for any practitioner of analytical science related to pharmaceutical and diagnostics development.

Text Copyright © 2019 Katrina Rogers