WEBINAR: The New Drug /Biologics Licenses Applications Review Process. What is all the fuss?
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What to expect from this webinar:
This final webinar of the PHASTAR 3-part series will focus on interactions between FDA and applicants prior to and during the NDA/BLA review. In the first half of the webinar, Dr. LaRee Tracy will discuss the approach taken by CDER statisticians in the review of a NDA/BLA application, including how and what data are analyzed, the integrated review process, decisions on labeling and post-approval requirements, and interactions between the review team and the applicant during the review cycle. During the second half, Dr. Josh Baker will discuss the industry statistician’s demanding role in actively supporting a NDA/BLA Review, specifically their role as the technical lead of the statistics team and the process by which they react to FDA information requests and findings during the review cycle.
Want to learn more?
Part one, "The Role of Industry and FDA Statisticians: Who are they, what do they do and the vital role they serve" can be watched here.
Part two, "So, you want to meet with the FDA? Preparing for regulator meetings & how statisticians can influence these interactions" can be watched here.