Results 121 to 127 of about 5,527 (127)

Active Surveillance of Postmarket Medical Product Safety in the Federal Partners' Collaboration

Medical Care, 2012
After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they ...
Trinka S. Coster, Francesca E. Cunningham, Judith A. Racoosin, Chris Worrall, Melissa A. Robb, Summer Chapman   +5 more
openaire   +3 more sources

Evaluation of the Relative Abuse of an OROS Extended-release Hydromorphone HCI Product

The Clinical Journal of Pain, 2018
Objective: Formulating prescription opioids to limit abuse remains a priority. OROS extended-release (ER) hydromorphone HCl (EXALGO) may have lower abuse potential than many other opioid products. Three postmarketing studies of the relative abuse liability of OROS hydromorphone ER were conducted.
Butler, Stephen F., McNaughton, Emily C., Black, Ryan A., Cassidy, Theresa A   +3 more
openaire   +3 more sources

Postmarket surveillance of natural health products in Canada: clinical and federal regulatory perspectivesThis article is one of a selection of papers published in this special issue (part 1 of 2) on the Safety and Efficacy of Natural Health Products.

Canadian Journal of Physiology and Pharmacology, 2007
Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP–drug interactions, or product quality.
openaire   +3 more sources

Postmarket surveillance and returned product analysis: Success but not transparency

Heart Rhythm, 2013
Robert M. Califf, Jonathan P. Piccini
openaire   +3 more sources

Foundational development of a postmarket surveillance program for e-vapor products using Internet forum data

Drug and Alcohol Dependence, 2017
Emily C. McNaughton, Taryn M. Dailey, M. Behling, Stephen F. Butler   +3 more
openaire   +2 more sources

PostMarket Surveillance of Medical Products in the United States

2010
Paul J. Seligman, Thomas P. Gross, M. Miles Braun, Janet B. Arrowsmith   +3 more
openaire   +1 more source

[Publications and postmarketing product surveillance: why and how?].

Annales francaises d'anesthesie et de reanimation, 1998
openaire   +1 more source