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An introspection of quality of novel drug approvals by United States Food and Drug Administration [PDF]

open access: goldInternational Journal of Basic & Clinical Pharmacology, 2018
Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel
Rekha Mehani, Ajay Kumar Shukla
core   +5 more sources

United States Food and Drug Administration seeks global regulatory regime [PDF]

open access: goldCanadian Medical Association Journal, 2011
The United States Food and Drug Administration (FDA) is proposing to develop and lead a more coordinated global approach to the inspection and monitoring of foods, drugs and medical devices. Globalization is forcing the development of a more coordinated international approach to regulation of ...
E. Walkinshaw
openalex   +3 more sources

Data from the United States Food and Drug Administration

open access: bronzeJAIDS Journal of Acquired Immune Deficiency Syndromes, 2005
Jenny Zheng
openalex   +4 more sources

Role of the U.S. Food and Drug Administration in the Regulatory Management of Human Listeriosis in the United States

open access: bronzeJournal of Food Protection, 2008
From 1986 to 2006, the incidence of listeriosis in the United States dropped from approximately seven to three cases per million population, a reduction that most likely reflects the joint efforts of industry, government, consumers, and academia. Herein, we describe the U.S.
Karl C. Klontz   +5 more
openalex   +4 more sources

Long-Read Sequencing Reveals Evolution and Acquisition of Antimicrobial Resistance and Virulence Genes in Salmonella enterica

open access: yesFrontiers 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

Adverse drug event reports at the United States Food and Drug Administration Center for Veterinary Medicine [PDF]

open access: bronzeJournal of the American Veterinary Medical Association, 2004
Victoria Hampshire   +8 more
openalex   +4 more sources

Characterization of Biofilm Formation by Mycobacterium chimaera on Medical Device Materials

open access: yesFrontiers 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

bettercallsal: better calling of Salmonella serotypes from enrichment cultures using shotgun metagenomic profiling and its application in an outbreak setting

open access: yesFrontiers 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

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