Results 181 to 190 of about 13,126 (223)

A Postmarket Surveillance Benchmarking Exercise

Biomedical Instrumentation & Technology, 2014
Monitoring device performance after a product has been launched is a critical aspect of maintaining product safety. Not only is it the right thing to do, but our regulators expect that it’s done. • FDA 21 CFR 822 discusses monitoring and evaluation of product performance data.
Pat, Baird, Andrea, Schwartz
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FDA Oversight of Postmarketing Studies

New England Journal of Medicine, 2017
The FDA aims to ensure the timely dissemination of information from postmarketing studies of drugs. The authors argue that an analysis of the effect of the FDA Amendments Act would evaluate the timeliness of FDAAA postmarketing requirements separately from that of other types of requirements.
Mwango, Kashoki, Cathryn, Lee, Peter, Stein   +2 more
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Postmarketing Surveillance for Oncology Drugs

Clinical Journal of Oncology Nursing, 2008
Adverse effects of cancer therapies may occur more than three decades after drug administration. Continued vigilance in postmarketing use of oncology agents is necessary to accurately track adverse effects, update prescribing information, and alert healthcare providers in a timely manner.
Pamela Hallquist, Viale, Susan, Moore
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Postmarketing Surveillance: Beyond medWatch

JAMA: The Journal of the American Medical Association, 1993
To the Editor. —As one who has actively participated in adverse effects surveillance over the past 10 years, 1,2 I wish to applaud the new Food and Drug Administration (FDA)MEDWATCHinitiative. 3 The FDA commissioner and his staff are to be congratulated on recognizing that major efforts must be made to heighten awareness of the importance of reporting
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Pemoline Hepatotoxicity and Postmarketing Surveillance

Journal of the American Academy of Child & Adolescent Psychiatry, 2001
To review the numerous reports of hepatotoxic adverse drug reactions (ADRs) ascribed to pemoline that were sent to the U.S. Food and Drug Administration (FDA) between 1975 and 1996 and to describe the medical community's lack of awareness of these reports.All ADR reports from 1975 through 1996 wherein pemoline was the suspect agent were obtained from ...
D J, Safer, J M, Zito, J E, Gardner
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Postmarketing Trials for Rare Diseases

Science, 2012
We fully agree with the Policy Forum “Rethinking research ethics: The case of postmarketing trials” (4 May, p. [544][1]), in which A. J. London et al. argue for rigorous, ethical, postmarketing (phase IV) trials for licensed drugs.
Virginia A, Llera, Emilio J A, Roldán
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MS treatment: Postmarketing studies

Journal of the Neurological Sciences, 2007
Multiple sclerosis (MS) is an inflammatory chronic demyelinating disease. Nowadays, there are several registered drugs aimed to control the disease activity. Because these drugs are given parenterally for years, it is of utmost importance to attain maximum adherence to treatment through close and permanent care of patients.
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Cefmetazole postmarketing surveillance in Japan

Journal of Antimicrobial Chemotherapy, 1989
The Sankyo Company Ltd had conducted a postmarketing surveillance programme on cefmetazole sodium since its marketing introduction in Japan. Two data collection approaches were used: a survey in which participating physicians provided complete information on all their patients who received cefmetazole for treatment of infection, and two voluntary ...
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Drug Postmarketing Studies

JAMA, 2013
Mwango, Kashoki, Cathryn, Lee, John, Jenkins   +2 more
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Concerns with postmarketing surveillance

American Journal of Health-System Pharmacy, 1984
M J, Norvell, R J, Anderson
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