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Unapproved New Drugs/MisbrandedMedisourceRx. Los Alamitos, CA. 483 issued 06/10/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/10/2025
Short Title (70 char) MedisourceRx. Los Alamitos, CA. 483 issued 06/10/2025
FEI Number 3013316698
Firm Name MedisourceRx
Record Type 483
State CAWalgreen Company – 662158 – 12/19/2025
Failure to Register and ListFDA use of Real-World Evidence in Regulatory Decision Making
The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) applied RWE in regulatory decision-making processes since 2011.Middlefield Original Cheese Co-Op Recalls 100% Grass-Fed Pepper Jack Cheese and Horseradish Flavored Cheese Due to Possible Listeria monocytogenes Contamination
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GE HealthCare is correcting Carestations that may not ventilate properly in VCV mode. The issue is clearly indicated by alarms; other modes remain effective.