Results 1 to 10 of about 687,018 (362)

Food and Drug Administration [PDF]

open access: yesBMJ, 2007
More independent resources and alternative ways to identify adverse events are ...
Linda R Horton
semanticscholar   +3 more sources

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
openaire   +3 more sources

US Food and Drug Administration [PDF]

open access: yesThe Palgrave Encyclopedia of Interest Groups, Lobbying and Public Affairs, 2021
Barbara Desanto
semanticscholar   +2 more sources

Adverse Drug Reactions and Toxicity of the Food and Drug Administration–Approved Antisense Oligonucleotide Drugs

open access: yesDrug Metabolism And Disposition, 2022
The market for large molecule biologic drugs has grown rapidly, including antisense oligonucleotide (ASO) drugs. ASO drugs work as single-stranded synthetic oligonucleotides that reduce production or alter functions of disease-causing proteins through ...
Feryal Alhamadani   +7 more
semanticscholar   +1 more source

US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018

open access: yesJAMA Network Open, 2022
This cohort study evaluates how the US Food and Drug Administration (FDA) accelerated approval program has been used for nononcology drugs over a period of 26 years.
Kenji Omae   +3 more
semanticscholar   +1 more source

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

Absorption, Distribution, Metabolism, and Excretion of US Food and Drug Administration–Approved Antisense Oligonucleotide Drugs

open access: yesDrug Metabolism And Disposition, 2022
Absorption, distribution, metabolism, and excretion (ADME) are the key biologic processes for determination of a drug’s pharmacokinetic parameters, which have direct impacts on efficacy and adverse drug reactions (ADRs).
Julia M. Migliorati   +8 more
semanticscholar   +1 more source

Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action

open access: yesJAMA Network Open, 2021
Key Points Question How often are anticancer drugs approved based on a new mechanism of action? Findings In this cross-sectional study of 332 US Food and Drug Administration–approved anticancer drugs from 2009 to 2020, 16% of approvals were based on a ...
T. Olivier, A. Haslam, V. Prasad
semanticscholar   +1 more source

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