lunes, 24 de agosto de 2026
Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications June 23, 2026
https://www.fda.gov/drugs/news-events-human-drugs/office-new-drugs-standard-safety-tables-and-figures-new-drug-and-biologic-applications-06232026?utm_medium=email&utm_source=govdelivery
SBIA invites you to view our latest On-Demand webinar, Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications.
The goal of this training is to provide participants with information on the standard safety tables and figures integrated guide and CDER's Manual of Policies and Procedures (MAPP) for the premarket safety evaluation of new drug and biologic products. Attendees will gain knowledge of the presentation and analyses for tables and figures that the Office of New Drugs considers important understanding drug applications, including adverse events, subgroups, laboratory, and vital signs analyses. Viewers will also gain a general overview of the Targeted Analysis Guides.
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