Drug Development Tool (DDT) Qualification Programs
Information about the mission and objectives of FDA’s Drug Development Tool (DDT) qualification programs.
Biomarker Qualification Program
The Drug Development Tools (DDT) Research Grant Cycle for Fiscal Years (FY) 2024 is now open.
FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)
FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec,…
Chemical Analysis and Alkaloid Intake for Kratom Products Available in the United States
Kratom, Mitragyna speciosa, is a popular natural product in the United States to treat pain and opioid use disorder. A…
Exposure to Drugs of Abuse in Children and Adolescents Investigated by Hair Analysis
Results of hair analysis of children and adolescents confirm that the evaluation of drug exposure through hair analysis needs special…
Umary and Related Products
Information regarding Umary, a product marketed as a dietary supplement
Human Drug Compounding
Compounded drugs can serve an important medical need for certain patients, they also present a risk to patients.
FDA Rationale for Recognition Decision: Amoxicillin and Clavulanate against Haemophilus influenzae
FDA Rationale for Recognition Decision: Amoxicillin and Clavulanate against Haemophilus influenzae
FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal
FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal