United States Food and Drug Administration Product Label Changes. [PDF]
J Clin Aesthet Dermatol, 2016 Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch ...
Kircik L +3 more
europepmc +3 more sources
Frontiers in Microbiology, 2021 Salmonella enterica is a significant and phylogenetically diverse zoonotic pathogen. To understand its genomic heterogeneity and antimicrobial resistance, we performed long-read sequencing on Salmonella isolated from retail meats and food animals.
Cong Li +9 more
doaj +1 more source
Drug-associated congenital anomalies of the external ear identified in the United States food and drug administration adverse event reporting system database. [PDF]
Sci RepLi X, Hao J, Li D, Zhang R.
europepmc +2 more sources
Characterization of Biofilm Formation by Mycobacterium chimaera on Medical Device Materials
Frontiers in Microbiology, 2021 Non-tuberculous mycobacteria (NTM) are widespread in the environment and are a public health concern due to their resistance to antimicrobial agents. The colonization of surgical heater-cooler devices (HCDs) by the slow-growing NTM species Mycobacterium ...
Archana D. Siddam +6 more
doaj +1 more source
Suspected adverse drug reactions of rivaroxaban reported in the United States food and drug administration adverse event reporting system database: a pharmacovigilance study. [PDF]
Front PharmacolWu J +10 more
europepmc +2 more sources
Assessment of safety profile of secukinumab in real-world scenario using United States food and drug administration adverse event reporting system database. [PDF]
Sci RepEshwar V, Kamath A.
europepmc +3 more sources
Frontiers in Microbiology, 2023 Most current Salmonella subtyping analyses rely on whole genome sequencing (WGS), which focuses on the high-resolution analysis of single genomes or multiple single genomes from the isolated colonies on microbiological agar plates.
Kranti Konganti +12 more
doaj +1 more source
Unapproved drugs in the united states and the food and drug administration [PDF]
Advances in Therapy, 2011 Despite more than a century of evolving federal legislation, there remain many unapproved drugs on the United States (US) market. This article reviews the history of drug approval in the US, beginning with the landmark Pure Food and Drug Act of 1906, through to the development of the US Food and Drug Administration (FDA).
Matthew W. Davis +2 more
openaire +3 more sources
Machine learning models for rat multigeneration reproductive toxicity prediction
Frontiers in Pharmacology, 2022 Reproductive toxicity is one of the prominent endpoints in the risk assessment of environmental and industrial chemicals. Due to the complexity of the reproductive system, traditional reproductive toxicity testing in animals, especially guideline ...
Jie Liu +6 more
doaj +1 more source