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US Food and Drug Administration regulatory pesticide residue monitoring of human foods: 2009-2017
Food Additives and Contaminants Part A-chemistry Analysis Control Exposure & Risk Assessment, 2021Pesticides such as insecticides, fungicides, and herbicides can protect crops from insects, fungi, weeds, and other pests but must be applied following label instructions so that the pesticide residues in human and animal foods do not exceed maximum ...
Chia-Pei Liang+5 more
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The United States Food and Drug Administration
Cobert's Manual of Drug Safety and Pharmacovigilance, 2019The Food and Drug Administration ("FDA") recently updated its position on Bisphenol A ("BPA") citing certain studies as the basis for "some concern" about the potential effects of BPA on the brain, behavior, and prostate glands of fetuses, infants and ...
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Transparency at the Food and Drug Administration
New England Journal of Medicine, 2010The FDA recently released a report from its Transparency Task Force containing 21 draft proposals for expanding the disclosure of information by the agency while maintaining confidentiality for trade secrets and individually identifiable patient information. Afia Asamoah and Dr. Joshua Sharfstein from the FDA discuss the transparency initiative.
Afia K. Asamoah, Joshua M. Sharfstein
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JAMA Oncology, 2018
Importance Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or ...
J. Beaver+11 more
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Importance Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or ...
J. Beaver+11 more
semanticscholar +1 more source
Clinical pharmacology and therapy, 2020
Exposure–response (E–R) modeling provides a quantitative tool to leverage adult data to support pediatric trial design and drug approval. The pediatric E–R studies submitted to US Food and Drug Administration (FDA) between 2007 and 2018 were surveyed in ...
Yifei Zhang+8 more
semanticscholar +1 more source
Exposure–response (E–R) modeling provides a quantitative tool to leverage adult data to support pediatric trial design and drug approval. The pediatric E–R studies submitted to US Food and Drug Administration (FDA) between 2007 and 2018 were surveyed in ...
Yifei Zhang+8 more
semanticscholar +1 more source
Drug Development, Guidelines, and the Food and Drug Administration
Annals of Internal Medicine, 1984Excerpt The costs of arthritis to society are climbing to an estimated $13.5 billion per year (1).
Allen H. Mackenzie, Sanford H. Roth
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