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Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study.

BMJ
Everhart AO, Karaca-Mandic P, Redberg RF, Ross JS, Dhruva SS.   +4 more
europepmc   +1 more source

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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, 2021
Pesticides 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, C. Sack, Sara McGrath, Yu Cao, Clinton J Thompson, Lauren Posnick Robin   +5 more
semanticscholar   +1 more source

The United States Food and Drug Administration

Cobert's Manual of Drug Safety and Pharmacovigilance, 2019
The 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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The US Food and Drug Administration's Model‐Informed Drug Development Meeting Program: From Pilot to Pathway

Clinical pharmacology and therapy
New drug development is a multifaceted, complex, high-risk endeavor involving a range of scientific, financial, and regulatory challenges. Innovative technologies, tools, and approaches have been proposed to increase drug development efficiency and the ...
R. Madabushi, Jessica Benjamin, Hao Zhu, I. Zineh   +3 more
semanticscholar   +1 more source

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review

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, L. Howie, Lorraine C Pelosof, Tamy Kim, Jinzhong Liu, Kirsten B. Goldberg, R. Sridhara, G. Blumenthal, A. Farrell, P. Keegan, R. Pazdur, P. Kluetz   +11 more
semanticscholar   +1 more source

Exposure–Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration

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, Yaning Wang, Mona Khurana, H. Sachs, Hao Zhu, G. Burckart, J. Alexander, L. Yao, Jian Wang   +8 more
semanticscholar   +1 more source