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 […]

FOOD AND DRUG ADMINISTRATIONCENTER FOR DRUG EVALUATION AND RESEARCH With Therapeutic Equivalence Evaluations PREFACE TO FORTY FOURTH EDITION The publication, Approved Drug Products With Therapeutic Equivalence Evaluations […]

The research studies conducted under the Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new […]

Summary of Proceedings FDA virtually convened its 12th intergovernmental working meeting on drug compounding with state government officials on November 7 and 8, 2023. Attendees included […]

Many serious patient illnesses and deaths linked to poor quality compounded drugs have occurred since the 2012 fungal meningitis outbreak. In response, FDA has established an […]