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Drugs, Devices, and the FDA: Part 1
Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world.
Gail A. Van Norman, MD
doaj +1 more source
FDA approved drugs with pharmacotherapeutic potential for SARS-CoV-2 (COVID-19) therapy
In December 2019, a novel SARS-CoV-2 coronavirus emerged, causing an outbreak of life-threatening pneumonia in the Hubei province, China, and has now spread worldwide, causing a pandemic.
Sylwester Drożdżal +6 more
semanticscholar +1 more source
Drugs, Devices, and the FDA: Part 2
As with new drugs, the U.S. Food and Drug Administration’s approval process is intended to provide consumers with assurance that, once it reaches the market place, a medical device is safe and effective in its intended use.
Gail A. Van Norman, MD
doaj +1 more source
An update in drug use during pregnancy: risk classification [PDF]
Objective: To review medicines pregnancy category and establish the degree of conformity between the two systems more used: FDA (Food and Drug Administration) and ACPM (advisory Committee on Prescription Medicines). Methods: drugs used in most frequent
M. Gallego Úbeda +4 more
doaj +1 more source
Docking-based virtual screening of known drugs against murE of Mycobacterium tuberculosis towards repurposing for TB. [PDF]
Repurposing has gained momentum globally and become an alternative avenue for drug discovery because of its better success rate, and reduced cost, time and issues related to safety than the conventional drug discovery process.
Brindha, Sridharan +4 more
core +1 more source
Predicting Drug–Drug Interactions: An FDA Perspective [PDF]
Pharmacokinetic drug interactions can lead to serious adverse events, and the evaluation of a new molecular entity's drug-drug interaction potential is an integral part of drug development and regulatory review prior to its market approval. Alteration of enzyme and/or transporter activities involved in the absorption, distribution, metabolism, or ...
Lei, Zhang +3 more
openaire +2 more sources
(1) Background: Drug repositioning is an unconventional drug discovery approach to explore new therapeutic benefits of existing drugs. Currently, it emerges as a rapid avenue to alleviate the COVID-19 pandemic disease.
A. Mostafa +19 more
semanticscholar +1 more source
Antiviral Efficacies of FDA-Approved Drugs against SARS-CoV-2 Infection in Ferrets
The SARS-CoV-2 pandemic continues to spread worldwide, with rapidly increasing numbers of mortalities, placing increasing strain on health care systems.
Su-Jin Park +18 more
semanticscholar +1 more source
Objective To determine differences in the characteristics of cancer drugs designated as orphan drugs by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).Design and setting Identification of all cancer drugs (initial or ...
Aaron S Kesselheim +1 more
doaj +1 more source
Drug repositioning represents an effective way to control the current COVID-19 pandemic. Previously, we identified 24 FDA-approved drugs which exhibited substantial antiviral effect against SARS-CoV-2 in Vero cells.
Meehyun Ko +3 more
semanticscholar +1 more source

