Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue

GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality, and affordable generics.

This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices.

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 Ou

NATCO Pharma Limited – 6/19/2025. Country: India. Record Type: 483

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Unapproved New Drugs/Adulterated/Misbranded