FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: USE OF BAYESIAN METHODOLOGY IN CLINICAL TRIALS OF DRUG AND BIOLOGICAL PRODUCTS; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Jan. 12 -- Food and Drug Administration has issued a notice called: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Jan. 12 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products." This document provides guidance on the appropriate use of Bayesian methods in clinical trials. The primary focus is on the use of Bayesian methods to support primary inferenc...