The Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating through grants or contracts.
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Wedgewood Connect, LLC. San Jose, CA. 483 issued 07/03/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/03/2025
Short Title (70 char) Wedgewood Connect, LLC. San Jose, CA. 483 issued 07/03/2025
FEI Number 3003434972
Firm Name Wedgewood Connect, LLC
Record Type 483
State CA
Establishment Type Outsourcing FacilitClinical Decision Support Software
This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices.Rationale for FDA’s Position on Ceftazidime Breakpoints against Stenotrophomonas Maltophilia
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The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.Greco Gas, Inc. – 683090 – 08/12/2024
CGMP/Finished Pharmaceuticals/Adulterated
