Results 271 to 280 of about 25,779 (305)

Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration

Annals of Internal Medicine, 2020
BACKGROUND Vaccines are one of the greatest achievements in public health. Prevalence and clinical significance of emerging postapproval, vaccine-related safety issues have not been systematically studied.
Noam Tau, D. Yahav, D. Shepshelovich
semanticscholar   +1 more source

Finasteride and Suicide: A Postmarketing Case Series

Dermatology, 2020
Background: In 2011, depression was added to the product labeling of finasteride in the USA. The US Food and Drug Administration’s Adverse Event Reporting System database contains at least 36 death cases for finasteride.
M. Irwig
semanticscholar   +1 more source

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.
Andrea Schwartz, Pat Baird
openaire   +3 more sources

Postmarketing Surveillance in Canada

Drug Information Journal, 1996
This paper provides an overview of the history of Canada's adverse drug reaction monitoring program. The program's place within Health Canada is covered, as are development activities over the last five years. Further intentions and international harmonization initiatives are highlighted.
openaire   +2 more sources

The utilization and challenges of Japan's MID‐NET® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies

Pharmacoepidemiology and Drug Safety, 2019
To examine the potential role of Medical Information Database Network (MID‐NET®), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations ...
Kaori Yamada, Maori Itoh, Yoshiaki Fujimura, M. Kimura, K. Murata, N. Nakashima, M. Nakayama, K. Ohe, T. Orii, Eizaburo Sueoka, Takahiro Suzuki, H. Yokoi, Chieko Ishiguro, Y. Uyama   +13 more
semanticscholar   +1 more source

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 ...
openaire   +3 more sources

Alosetron Postmarketing Experience

Clinical Pharmacology & Therapeutics, 2003
Clinical Pharmacology & Therapeutics (2003) 73, P34–P34; doi:
S. Kress, Allen Brinker, J. Beitz, A.C. Mackey   +3 more
openaire   +2 more sources

New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence

Drug Safety, 2022
Osman Moneer, B. L. Brown, J. Avorn, Jonathan J. Darrow, Mayookha Mitra-Majumdar, Krysten W. Joyce, Murray N. Ross, Catherine Pham, A. Kesselheim   +8 more
semanticscholar   +1 more source

Postmarketing Surveillance of Drugs*

2020
Most efforts in postmarketing surveillance are directed at the design of methods to collect information on newly marketed drugs. In the review by Medicine in the Public Interest the majority of fatal adverse reactions seemed to be due to older, standard drugs.
openaire   +2 more sources

Postmarketing studies of drug safety

BMJ, 2011
A European initiative could help bring more transparency and rigour to ...
Jerry Avorn, Sebastian Schneeweiss
openaire   +3 more sources