Results 1 to 10 of about 687,018 (362)
Food and Drug Administration [PDF]
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]
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]
Barbara Desanto
semanticscholar +2 more sources
The milk and food program of the Food and Drug Administration. [PDF]
John H. Fritz
openaire +4 more sources
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
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
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 (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
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