Results 201 to 210 of about 999,693 (251)
Some of the next articles are maybe not open access.
The American Journal of Medicine, 2021
In 2020, the US Food and Drug Administration approved 53 novel drugs. Thirty-six of the 53 (68%) drugs were reviewed and approved through an expedited review pathway, and 31 of the 53 (58%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the US Food and Drug Administration in 2020.
Alex M Ebied +2 more
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In 2020, the US Food and Drug Administration approved 53 novel drugs. Thirty-six of the 53 (68%) drugs were reviewed and approved through an expedited review pathway, and 31 of the 53 (58%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the US Food and Drug Administration in 2020.
Alex M Ebied +2 more
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Drug Approval and Surveillance
International Journal of Gynecology & Obstetrics, 1980ABSTRACTThe author proposes that current regulations governing the licensing of drugs, particularly in the United States, need to be changed and replaced by a system of provisional or conditional licensing and increased postmarketing surveillance of drug use.
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Science, 2017
As the Trump administration takes shape, there is much speculation as to what major changes will be made. A dominant theme of the Trump campaign was to cut through bureaucracy in Washington, D.C., thereby enhancing innovation and bringing new technology to Americans more quickly.
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As the Trump administration takes shape, there is much speculation as to what major changes will be made. A dominant theme of the Trump campaign was to cut through bureaucracy in Washington, D.C., thereby enhancing innovation and bringing new technology to Americans more quickly.
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New drug approvals in oncology
Nature Reviews Clinical Oncology, 2020The traditional regulatory drug approval paradigm comprising discrete phases of clinical testing that culminate in a large randomized superiority trial has historically been predominant in oncology. However, this approach has evolved in the current era of drug development, with multiple other development pathways now being utilized.
Razelle, Kurzrock +3 more
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Drugs approved for small ruminants
Journal of the American Veterinary Medical Association, 2004JAVMA, Vol 224, No. 4, February 15, 2004 F the purpose of this FARAD Digest, small ruminants are considered to include sheep, goats, deer, and camelids. In the United States, the small ruminant population is low, and they are all considered minor species under the Food, Drug, and Cosmetics Act (Table 1).
Alistair I, Webb +4 more
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Nature Reviews Drug Discovery, 2015
The FDA approved 41 new therapeutics in 2014, but the bumper year fell short of the commercial power of the drugs approved in 2013.
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The FDA approved 41 new therapeutics in 2014, but the bumper year fell short of the commercial power of the drugs approved in 2013.
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Tardive Dyskinesia Drug Approved
JAMA, 2017The first drug for adults with tardive dyskinesia (TD) has received FDA approval. Tardive dyskinesia is a neurological disorder that causes repetitive, involuntary movements such as abnormal tongue and lip movements, cheek bulging, foot tapping, shoulder shrugging, and rocking and swaying movements.
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The Nurse Practitioner, 2014
This article highlights important prescribing information for new drugs approved by the FDA over the last year. These include albiglutide, apremilast, dapagliflozin, insulin human inhalation powder, riociguat, timothy grass pollen allergen extract, umeclidinium and vilanterol inhalation powder, and vorapaxar.
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This article highlights important prescribing information for new drugs approved by the FDA over the last year. These include albiglutide, apremilast, dapagliflozin, insulin human inhalation powder, riociguat, timothy grass pollen allergen extract, umeclidinium and vilanterol inhalation powder, and vorapaxar.
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Accelerating drug development and approval
Drug News & Perspectives, 2010Regulatory agencies are the gateway between the pharma/biotech industry and patients and can serve as stimulators of new drug development. This article highlights several means of doing so implemented thus far, many with already impressive histories, such as orphan drug legislation, and others of a more experimental nature, such as the FDA's priority ...
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