In the announcement, FDA Commissioner Mackary said, “Bayesian methodologies help address two of the biggest problems of drug ...
Above is a simulated charge sensor signal and its histogram. Below is a time integration that reduces noise and enables state identification (called threshold judgment, a conventional method). A ...
A research team at Tohoku University's Advanced Institute for Materials Research (WPI-AIMR) has developed a new technique to rapidly and accurately determine the charge state of electrons confined in ...
WASHINGTON, Jan. 20, 2026 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has issued new draft guidance modernizing statistical methodologies used in clinical trials, formally recognizing ...
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 ...
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, ...
We review Bayesian and Bayesian decision theoretic approaches to subgroup analysis and applications to subgroup-based adaptive clinical trial designs. Subgroup analysis refers to inference about ...
What physicians should know about FDA's new proposed guidance ...
Industry groups and drugmakers want the US Food and Drug Administration (FDA) to explicitly clarify that Bayesian statistical methods can be used for products beyond those intended for children and ...