post-marketing surveillance


Also found in: Acronyms.

post-·mar·ket·ing sur·veil·lance

procedure implemented after a drug has been licensed for public use, designed to provide information on use and on occurrence of side effects, adverse effects, etc.

post-marketing surveillance

Ongoing safety monitoring—e.g., in Phase-4 and Phase-5 studies—of marketed drugs.
References in periodicals archive ?
Executives shared their strategies, lessons learned, and best practices on Post-Marketing Surveillance.
PP-WE-579: Inhibitor formation with sucrose-formulated recombinant factor VIII in patients with hemophilia A: Results from post-marketing surveillance studies.
This benchmarking study examines the best practices for post-marketing surveillance within the United States, as well as the processes for assessing reports of adverse events, follow-up activities and compliance training.
The system is easily accessed over the Internet, simple to use, requires absolutely no installation, and the interface has proved to be very appealing to professional end users," said Roland Rutschmann, General Manager and Project Sponsor for Actelion's first post-marketing surveillance project.
The post-marketing surveillance study was introduced in 1987 following the introduction of Genotropin in a number of countries throughout the world.
The final results from this post-marketing surveillance study, conducted by Dr.
Given the extensive clinical evidence covering over 70,000 patients and the results of post-marketing surveillance arising from 24 million patient-years of experience, Sanofi-Aventis stands behind the safety of Lantus," Lehner said.
The conditions for approval were given as: "Because of a very limited number of the subjects treated in the domestic clinical trials, a post-marketing surveillance of all patients who received Avastin(R) after the launch of it should be conducted until the data of a certain number of patients are accumulated in order to identify the background of the patients and collect the safety and efficacy data of them early, and take necessary measures for proper use of Avastin(R).
The approvable letter contains proposed labeling, as well as requests for data clarification, post-marketing surveillance, and post- marketing studies.
Tokyo, Japan, Dec 21, 2005 - (JCN) - Soiken has agreed with Hakuhodo, a wholly owned subsidiary of Hakuhodo DY Holdings, to establish a joint venture company for post-marketing surveillance (PMS) studies and marketing research for food for specified health use (FOSHU).
In addition to mandated conditional regulatory approval or post-marketing surveillance trials, other reasons sponsors may conduct post-marketing trials include: