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FDA Modernization Act 2.0 allows for alternatives to animal testing.
Artificial Organs, 2023On December 29, 2022, President Biden signed into law the FDA Modernization Act 2.0. The bill essentially refutes the Federal Food, Drug, and Cosmetics Act of 1938, which mandated animal testing for every new drug development protocol. While for the past
Jason J. Han
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U.S. FDA Approved Drugs from 2015-June 2020: A Perspective.
Journal of Medicinal Chemistry, 2021In the present work, we report compilation and analysis of 245 drugs, including small and macromolecules approved by the U.S. FDA from 2015 until June 2020. Nearly 29% of the drugs were approved for the treatment of various types of cancers.
Priyadeep Bhutani+7 more
semanticscholar +1 more source
New England Journal of Medicine, 2014
Because of a warning from the FDA, 23andMe has stopped marketing its personal genome service. Now, a dialogue about key issues in genomic testing could result in clear standards for the industry, including requirements for informed consent and disclosure of results.
Koichiro Yuji+2 more
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Because of a warning from the FDA, 23andMe has stopped marketing its personal genome service. Now, a dialogue about key issues in genomic testing could result in clear standards for the industry, including requirements for informed consent and disclosure of results.
Koichiro Yuji+2 more
openaire +6 more sources
FDA finds that FDA is not biased [PDF]
Following a year-long in-house investigation of employee allegations that the Food & Drug Administration is biased toward the drug industry, Commissioner Alexander M. Schmidt has concluded that not only is there "no evidence to support such charges," but that "there is evidence to refute them." In a 906-page report issued earlier this month, Dr ...
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Journal of Medicinal Chemistry, 2014
Nitrogen heterocycles are among the most significant structural components of pharmaceuticals. Analysis of our database of U.S. FDA approved drugs reveals that 59% of unique small-molecule drugs contain a nitrogen heterocycle. In this review we report on
Edon Vitaku+2 more
semanticscholar +1 more source
Nitrogen heterocycles are among the most significant structural components of pharmaceuticals. Analysis of our database of U.S. FDA approved drugs reveals that 59% of unique small-molecule drugs contain a nitrogen heterocycle. In this review we report on
Edon Vitaku+2 more
semanticscholar +1 more source
A Decade of FDA-Approved Drugs (2010-2019): Trends and Future Directions.
Journal of Medicinal Chemistry, 2021A total of 378 novel drugs and 27 biosimilars approved by the U.S. Food and Drug Administration (FDA) between 2010 and 2019 were evaluated according to approval numbers by year, therapeutic areas, modalities, route of administration, first-in-class ...
Dean G. Brown, Heike J Wobst
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New England Journal of Medicine, 2015
The FDA has recommended a pathway to expedite completion of studies to ensure that new sunscreen ingredients are safe and effective. A renewed commitment to collaboration on high-quality studies could lead to breakthroughs in melanoma prevention.
Stephen Ostroff, Robert M. Califf
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The FDA has recommended a pathway to expedite completion of studies to ensure that new sunscreen ingredients are safe and effective. A renewed commitment to collaboration on high-quality studies could lead to breakthroughs in melanoma prevention.
Stephen Ostroff, Robert M. Califf
openaire +3 more sources
The American Journal of Digestive Diseases, 1977
Carbenoxolone, cimetidine, and chenodeoxycholic acid are unavailable in the United States. Other pharmacologic agents such as lactulose and pentagastrin have recently become available, but only many years after they were demonstrated to be both safe and effective.
Alastair M. Connell, William H. Bachrach
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Carbenoxolone, cimetidine, and chenodeoxycholic acid are unavailable in the United States. Other pharmacologic agents such as lactulose and pentagastrin have recently become available, but only many years after they were demonstrated to be both safe and effective.
Alastair M. Connell, William H. Bachrach
openaire +3 more sources