C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of their applicability, opportunities, and challenges.
Similar Posts
In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula
[New York, NY] – ByHeart, a next-generation baby nutrition company, announced today that, out of an abundance of caution, it has chosen to voluntarily recall two batches of ByHeart Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration (FDA) of a broader ongOffice of Generic Drugs | Offices and Divisions
Generic Drugs Offices and DivisionsTable of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure
FDA’s surrogate endpoint table provides valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs.Apotex Inc. – 05/09/2025
Apotex Inc. – 05/09/2025. Country: Canada. Record Type: 483Current Good Manufacturing Practice for Medical Gases
Pharmaceutical Quality/Manufacturing Standards (CGMP)Lockout Supplements Issues Voluntary Nationwide Recall of Boner Bears Chocolate Syrup Due to Undeclared Sildenafil
02/252026-McKinney, Texas, Lockout Supplements is voluntarily recalling all lots of Boner Bears Chocolate Syrup. This product has been found to contain sildenafil not listed on the product label.
