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Functional foods: the Food and Drug Administration perspective [PDF]

open access: bronzeThe American Journal of Clinical Nutrition, 2000
Because the Federal Food, Drug, and Cosmetic Act (FFDCA) does not provide a statutory definition of functional foods, the Food and Drug Administration has no authority to establish a formal regulatory category for such foods. The primary determinant of the regulatory status of a food is its intended use, which is determined largely by the label and ...
Sharon G. Ross
openalex   +3 more sources

The contribution of smoking-attributable mortality to differences in mortality and life expectancy among US African-American and white adults, 2000-2019

open access: yesDemographic Research, 2022
Background: The role of smoking in racial disparities in mortality and life expectancy in the United States has been examined previously, but up-to-date estimates are generally unavailable, even though smoking prevalence has declined in recent decades.
Brian L. Rostron   +5 more
doaj   +1 more source

Applications of artificial intelligence in drug development using real-world data [PDF]

open access: yesDrug Discovery Today 2020, 2021
The US Food and Drug Administration (FDA) has been actively promoting the use of real-world data (RWD) in drug development. RWD can generate important real-world evidence reflecting the real-world clinical environment where the treatments are used. Meanwhile, artificial intelligence (AI), especially machine- and deep-learning (ML/DL) methods, have been
arxiv   +1 more source

Dimensional variability characterization of additively manufactured lattice coupons

open access: yes3D 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   +7 more
doaj   +1 more source

The FDA’s Diverse and Dynamic Activities in the Social and Behavioral Sciences: Advancing and Supporting Health Equity

open access: yesJournal of Primary Care & Community Health, 2021
The U.S. encompasses a heterogenous mix of people and health disparities exist for various subpopulations, such as minorities, women, people with limited English proficiency, those with low socioeconomic status, and other underserved groups.
Christine Lee   +10 more
doaj   +1 more source

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

open access: yesBMC 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   +2 more
doaj   +1 more source

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

open access: yesFrontiers 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   +11 more
doaj   +1 more source

Informing selection of drugs for COVID-19 treatment through adverse events analysis

open access: yesScientific Reports, 2021
Coronavirus disease 2019 (COVID-19) is an ongoing pandemic and there is an urgent need for safe and effective drugs for COVID-19 treatment. Since developing a new drug is time consuming, many approved or investigational drugs have been repurposed for ...
Wenjing Guo   +10 more
doaj   +1 more source

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