Results 201 to 210 of about 18,936 (261)
Advanced Science, EarlyView.A pneumatically actuated multi‐tissue microphysiological system is integrated with AI‐based machine vision and automatic sampling and replenishment systems. The platform allows for the emulation of translationally relevant long‐term pharmacokinetic exposure scenarios for multiple weeks while enabling longitudinal monitoring of response biomarkers ...
Jibbe Keulen +15 more
wiley +1 more source
Advanced Science, EarlyView.Conjugated poly(imide dioxime)‐based microspheres establish a radiometal coordination‐driven conformational interlocked network with ultra‐high radiostability. This platform enables low‐temperature, multi‐radionuclide labeling for SPECT/PET/MRI imaging and radionuclide therapy. Mechanistic insights from EXAFS and DFT reveal enhanced stability, while in
Xiao Xu +10 more
wiley +1 more source
Advanced Science, EarlyView.An integrated probiotic system is engineered to execute a programmed therapeutic cascade against inflammatory bowel disease. Upon pathological signals, the system sequentially performs ROS scavenging, tungsten release, and selective pathogen suppression, thereby breaking the oxidative stress–dysbiosis cycle to remodel gut microbiota and reinforce ...
Yang Yang +8 more
wiley +1 more source
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FDA Regulation of Prescription Drugs
New England Journal of Medicine, 2017Over the past 5 years, the FDA has approved 182 new drugs. This overview explains the FDA’s drug-approval process, including its approach to benefit–risk assessment, drug labeling, risk evaluation and mitigation strategies, and postmarketing surveillance.
Audrey L, Gassman +2 more
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FDA-Approved Fluorinated Heterocyclic Drugs from 2016 to 2022 [PDF]
International Journal of Molecular Sciences, 2023 The inclusion of fluorine atoms or heterocyclic moiety into drug structures represents a recurrent motif in medicinal chemistry. The combination of these two features is constantly appearing in new molecular entities with various biological activities ...
Carla Rizzo, Sara Amata, Ivana Pibiri
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Science, 2005
We are concerned about misinformation in the News Focus article “Lupus drug company asks FDA for second chance” (J. Couzin, 11 Feb., p. [835][1]). It is not true that the U.S. Food and Drug Administration (FDA) has rejected the medication LJP 394, which is under active development by La Jolla Pharmaceutical Company.
Joan T, Merrill, Sandra, Raymond
openaire +2 more sources
We are concerned about misinformation in the News Focus article “Lupus drug company asks FDA for second chance” (J. Couzin, 11 Feb., p. [835][1]). It is not true that the U.S. Food and Drug Administration (FDA) has rejected the medication LJP 394, which is under active development by La Jolla Pharmaceutical Company.
Joan T, Merrill, Sandra, Raymond
openaire +2 more sources
2022
How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work.
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How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work.
openaire +1 more source
FDA drug classification system
American Journal of Health-System Pharmacy, 1991The purpose and use of the FDA's classification system for new drug products are described. Investigational new drug applications (INDs) and new drug applications (NDAs) are submitted to the FDA's Center for Drug Evaluation and Research. To establish the priority of the product in the review process, expert reviewers classify each product according to ...
M D, Sanborn, H N, Godwin, J D, Pessetto
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The FDA and Hypoglycemic Drugs
JAMA: The Journal of the American Medical Association, 1975THE NELSON Committee hearings in the US Senate (Sept 18 to 20, 1974) explored thesafety, effectiveness, anduseof hypoglycemic drugs. A dozen witnesses, including the Food and Drug Administration (FDA) Commissioner Dr. Alexander Schmidt, gave testimony concerning the implications of the University Group Diabetes Program (UGDP) articles for medical ...
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Drug Intelligence & Clinical Pharmacy, 1983
The Food and Drug Administration (FDA) has been criticized for publicly announcing the approval of significant new drugs. This policy was formulated for two reasons: to encourage better public understanding of the benefits and limitations of new drugs and to account to the public for new drug approvals.
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The Food and Drug Administration (FDA) has been criticized for publicly announcing the approval of significant new drugs. This policy was formulated for two reasons: to encourage better public understanding of the benefits and limitations of new drugs and to account to the public for new drug approvals.
openaire +2 more sources