Results 1 to 10 of about 787,943 (334)

United States Food and Drug Administration Drug Approval Summary

Clinical Cancer Research, 2004
Abstract On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
Martin H. Cohen, Grant A. Williams, Rajeshwari Sridhara, Gang Chen, W. David McGuinn, David Morse, Sophia Abraham, Atiqur Rahman, Chenyi Liang, Richard Lostritto, Amy Baird, Richard Pazdur   +11 more
openaire   +3 more sources

The United States Food and Drug Administration and Prescription Drug Promotion. [PDF]

J Innov Card Rhythm Manag, 2019
The impact of prescription drug promotion on health-care professionals (HCPs) is significant. Pharmaceutical industry spending on promotion to HCPs greatly outpaces spending on direct-to-consumer promotion. According to Syneos Health™ PromotionalAnswers, in 2017, the pharmaceutical industry spent more than $24 billion on drug promotion, with more than $
Kalola AS, Dean R.
europepmc   +4 more sources

Unrecognized maternal heart rate artefact in cases of perinatal mortality reported to the United States Food and Drug Administration from 2009 to 2019: a critical patient safety issue. [PDF]

BMC Pregnancy Childbirth, 2019
BackgroundMaternal heart rate artefact is a signal processing error whereby the fetal heart rate is masked by the maternal pulse, potentially leading to danger by failure to recognize an abnormal fetal heart rate or a pre-existing fetal death.
Kiely DJ, Oppenheimer LW, Dornan JC.
europepmc   +2 more sources

WHEELCHAIR SAFETY???ADVERSE REPORTS TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION

American Journal of Physical Medicine & Rehabilitation, 1994
Evidence has been accumulating that injuries related to wheelchair use are common and sometimes serious. The object of this study was to evaluate the databases of the Food and Drug Administration (FDA) for insights to the nature and causes of such problems. We analyzed 651 records that were received by the FDA between 1975 and 1993.
R L, Kirby, S A, Ackroyd-Stolarz
openaire   +3 more sources

A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration. [PDF]

J Pediatr, 2019
Liu XI, Schuette P, Burckart GJ, Green DJ, La J, Burnham JM, Rakhmanina N, Robb A, Huang SM, van den Anker JN.   +9 more
europepmc   +2 more sources

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, Sung JC, Stein-Gold L, Goldenberg G.   +3 more
europepmc   +3 more sources

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

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, Gregory H. Tyson, Chih-Hao Hsu, Lucas Harrison, Errol Strain, Thu-Thuy Tran, Glenn E. Tillman, Uday Dessai, Patrick F. McDermott, Shaohua Zhao   +9 more
doaj   +1 more source

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, Shari J. Zaslow, Yi Wang, K. Scott Phillips, Matthew D. Silverman, Patrick M. Regan, Jayaleka J. Amarasinghe   +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

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, Elizabeth Reed, Mark Mammel, Tunc Kayikcioglu, Rachel Binet, Karen Jarvis, Christina M. Ferreira, Rebecca L. Bell, Jie Zheng, Amanda M. Windsor, Andrea Ottesen, Christopher J. Grim, Padmini Ramachandran   +12 more
doaj   +1 more source

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, Wenjing Guo, Fan Dong, Jason Aungst, Suzanne Fitzpatrick, Tucker A. Patterson, Huixiao Hong   +6 more
doaj   +1 more source