Truseltiq (infigratinib) Treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other […]

For Immediate Release: May 24, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]

Listen Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin Advanced Practice Nurse. On […]

Listen Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information. On June […]

CDER provides scientific and regulatory advice to guide clinical trial development and implementation as a cornerstone in drug development, helping patients and consumers access the therapies […]

About DIRIL Dataset The DIRIL dataset is comprised of 317 single-molecule, oral administered drugs for human use, annotated for drug-induced renal injury (DIRI) and nephrotoxicity and […]

About DICTrank Dataset The DICTrank dataset contains the largest number of drugs ranked by their risk of drug-induced cardiotoxicity (DICT) using FDA-approved drug labeling documents. The […]

FDA’s generic drug Science and Research Program created under the Generic Drug User Fee Amendments (GDUFA) is an essential component of FDA’s mission to protect and […]

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Since launching our Overdose Prevention Framework in August, 2022, the FDA has taken some important […]