FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.
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Catalent 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.Wells Pharmacy LLC. Dyersburg, TN. Untitled Letter issued 10/14/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 10/14/2025
Short Title (70 char) Wells Pharmacy LLC. Dyersburg, TN. Untitled Letter issued 10/14/2025
FEI Number 3011761321
Firm Name Wells Pharmacy LLC
Record Type Untitled Letter
State TN
Establishment Type OuObstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) Roster
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The information in this section can help you work with your health professionals to make the best medicine choices, buy safely, and use medicine so it’s as safe and effective as possible.Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication – FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch
The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and o