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 ?
Based on type of clinical trial phases, the market is categorized in to preclinical studies, phase I, II, III, IV or post-marketing surveillance services market.
The authors write that post-marketing surveillance studies "may be insufficient for monitoring long-term, community-based outcomes," and that nationwide registries might be better able to fill that role.
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).
Due to the results of this study, and because "preliminary post-marketing surveillance reports from the United States suggest that two doses in the primary series are sufficient for protection, although additional information on the duration of protection is needed," the authors suggested that the use of fewer than four doses may be a practical option for the administration of PCV7.
In addition to mandated conditional regulatory approval or post-marketing surveillance trials, other reasons sponsors may conduct post-marketing trials include:
Additionally, this study examines prescribing trends and the arrival of the first biosimilar agents and electronic records in post-marketing surveillance.
In a post-marketing surveillance study in the United States, treatment with OFEV in the real-world clinical setting showed a safety profile consistent with that observed in clinical trials supporting its approval by the FDA.
The FDA's decision will be based on data submitted from 13 placebo-controlled efficacy studies, and safety information from 43 clinical studies, as well as information from 16 years of post-marketing surveillance data.
Post-marketing surveillance practices, to assess the safety profiles of drugs that have already passed stringent regulatory scrutiny, have not always been a priority for many.
For example, do most medical device manufacturers with products on the market in Europe realize they must possess procedures for post-marketing surveillance (PMS)?