User Fee Lists
GDUFA User Fee Lists
-
-
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. -
Access, new active substance and biosimilar work sharing initiatives
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
-
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis -
FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause
Listen to an audio podcast of the September 12th, 2024 FDA Drug Safety Communication on rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause. -
FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). -
Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
Listen to FDA Drug Safety Podcast, FDA’s preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions. -
FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). -
Firehook of Virginia Issues Allergy Alert on Undeclared Sesame in Classic Sea Salt Crackers
Firehook of Virginia is recalling one lot of Firehook brand Classic Sea Salt Organic Crackers because they may contain undeclared sesame.