Regulatory Affairs Professionals Society

This Week at FDA: Reactions to FDA’s Bayesian methods guidance, GDUFA science report, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, ...
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Comparative Study of Bayesian Information Borrowing Methods in Oncology Clinical Trials

Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study We divided the borrowing ...