Results 11 to 20 of about 687,018 (362)

Clinical Pharmacology of RNA Interference–Based Therapeutics: A Summary Based on Food and Drug Administration–Approved Small Interfering RNAs

Drug Metabolism And Disposition, 2022
RNA-based oligonucleotide therapeutics are revolutionizing drug development for disease treatment. This class of therapeutics differs from small molecules and protein therapeutics in various ways, including both its mechanism of action and clinical ...
Xing Jing, V. Arya, K. Reynolds, Hobart L Rogers   +3 more
semanticscholar   +1 more source

Perception of the Food and Drug Administration Electronic Cigarette Flavor Enforcement Policy on Twitter: Observational Study

JMIR Public Health and Surveillance, 2022
Background On January 2, 2020, the US Food and Drug Administration (FDA) released the electronic cigarette (e-cigarette) flavor enforcement policy to prohibit the sale of all flavored cartridge–based e-cigarettes, except for menthol and tobacco flavors ...
Xinyi Lu, Li Sun, Zidian Xie, Dongmei Li
semanticscholar   +1 more source

Food and Drug Administration perspective: Advancing product development for non‐healing chronic wounds

Wound Repair and Regeneration, 2022
The US Food and Drug Administration (FDA) understands that innovative product development is essential to addressing the unmet medical need of non‐healing chronic wounds.
K. Verma, Felisa Lewis, Maryjoy Mejia, Meghana Chalasani, Kendall A Marcus   +4 more
semanticscholar   +1 more source

Model‐Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates?

Clinical pharmacology and therapy, 2021
Antibody–drug conjugates (ADCs) combine the specificity of an antibody with the cytotoxicity of a chemical agent. They represent a rapidly evolving area of oncology drug development and hold significant promise.
Michael Z. Liao, D. Lu, M. Kågedal, D. Miles, D. Samineni, Stephanie N. Liu, Chunze Li   +6 more
semanticscholar   +1 more source

Dimensional variability characterization of additively manufactured lattice coupons

3D Printing in Medicine, 2022
Background Additive manufacturing (AM), commonly called 3D Printing (3DP), for medical devices is growing in popularity due to the technology’s ability to create complex geometries and patient-matched products.
Kirstie Lane Snodderly, Magdalene Fogarasi, Yutika Badhe, Ankit Parikh, Daniel Porter, Albert Burchi, Laura Gilmour, Matthew Di Prima   +7 more
doaj   +1 more source

Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration

PLoS Medicine, 2008
Background Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance.
I. Kirsch, B. Deacon, Tania B. Huedo-Medina, A. Scoboria, T. Moore, Blair T. Johnson   +5 more
semanticscholar   +1 more source

Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018)

BMC Health Services Research, 2021
Background A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program for certain medications with serious safety concerns required by the U.S. Food and Drug Administration (FDA) of manufacturers to implement to help ensure the benefits of
Linda Huynh, Gita A. Toyserkani, Elaine H. Morrato   +2 more
doaj   +1 more source

Outpatient Fluoroquinolone Prescription Fills in the United States, 2014 to 2020: Assessing the Impact of Food and Drug Administration Safety Warnings

Antimicrobial Agents and Chemotherapy, 2021
The impact of United States Food and Drug Administration (FDA) safety warnings on outpatient fluoroquinolone use is unclear. Annual changes in outpatient ciprofloxacin, levofloxacin, and moxifloxacin prescription fills (IQVIA National Prescription Audit ...
Deanna J. Buehrle, M. Wagener, C. Clancy
semanticscholar   +1 more source

Ecological prevalence, genetic diversity and epidemiological aspects of Salmonella isolated from tomato agricultural regions of the Virginia Eastern Shore

Frontiers in Microbiology, 2015
Virginia is the third largest producer of fresh-market tomatoes in the United States. Tomatoes grown along the eastern shore of Virginia are implicated almost yearly in Salmonella illnesses.
Rebecca L. Bell, Jie eZheng, Erik eBurrows, Sarah eAllard, Charles Y. Wang, Christine E. Keys, David C. Melka, Errol eStrain, Yan eLuo, Marc William Allard, Steven eRideout, Eric Wayne Brown   +11 more
doaj   +1 more source

Pharmacokinetic Drug-Drug Interactions with Drugs Approved by the US Food and Drug Administration in 2020: Mechanistic Understanding and Clinical Recommendations

Drug Metabolism And Disposition, 2021
Drug-drug interaction (DDI) data for small molecular drugs approved by the US Food and Drug Administration in 2020 (N = 40) were analyzed using the University of Washington Drug Interaction Database.
Jingjing Yu, Yan Wang, I. Ragueneau-Majlessi   +2 more
semanticscholar   +1 more source