User Fee Lists
GDUFA User Fee Lists
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Infusion Pump Correction: Baxter Updates Instructions for Use for Novum IQ Large Volume Pump due to Potential for Underinfusion
Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion -
2023 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee
This page contains the meeting materials for the Cardiovascular & Renal Drugs Advisory Committee meetings for 2023. -
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs
This guidance provides recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs. -
Newly Added Guidance Documents
Guidance documents represent the FDA’s current thinking on a particular subject. New guidance documents are listed here for three months.