E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
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North American Custom Laboratories LLC dba FarmaKeio Superior Custom Compounding. Richardson, TX. 483 issued 09/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) North American Custom Laboratories LLC dba FarmaKeio Superior Custom Compounding. Richardson, TX. 483 issued 09/05/2025
FEI Number 3014229024
Firm Name North American Custom LaboObstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) Roster
This page contains the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) Roster, which lists the current members and the current number of vacancies for the committee.Mellace Family Brands California, Inc. Recalls Wegmans Deluxe Mixed Nuts Unsalted, 34 oz and 11.5 oz Packages Because Of Possible Health Risk
Mellace Family Brands California, Inc. of Warren, OH has issued a recall for Wegmans Deluxe Mixed Nuts Unsalted 34 oz Tubs and Wegmans Deluxe Mixed Nuts Unsalted 11.5 oz bags because they have the potential to be contaminated with SalmonellaStellalife, Inc. – 712804 – 09/16/2025
Unapproved New Drugs/MisbrandedCatalent Indiana LLC, Bloomington, IN 483 Issued 07/14/2025
Catalent Indiana LLC, Bloomington, IN 483 Issued 07/14/2025Bayesian Statistical Analysis (BSA) Demonstration Project
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.
