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Functional foods: the Food and Drug Administration perspective [PDF]
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 milk and food program of the Food and Drug Administration. [PDF]
John H. Fritz
openalex +4 more sources
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]
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
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
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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
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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
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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
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Informing selection of drugs for COVID-19 treatment through adverse events analysis
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
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