SAN FRANCISCO — An estimated two out of five adult women in the United States have obesity, and given the potential challenges of losing pregnancy weight […]
BERLIN — New data from the SOFT and TEXT trials showed that women with premenopausal invasive lobular carcinoma, than those with invasive ductal carcinoma, experience a […]
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 […]
Personalized repetitive transcranial magnetic stimulation (rTMS) targeting the hippocampal network improved cognitive and functional performance in patients with early Alzheimer’s disease (AD), new research showed. The […]
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 […]
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