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 ?
Moreover, the increasing demand for early stage pre-clinical studies, clinical trials, post-marketing surveillance, and regulatory services are also expected to further drive the market over the forecast period.
Tony Leachon is right when he recently asked whether Sanofi has already submitted the post-marketing surveillance reports, as those missing reports are what made the FDA revoke Dengvaxia's CPR in the first place.
Furthermore, spontaneous reporting system of ADR is a basic component of post-marketing surveillance of drug-induced risks.
It offers clinical development services to the pharmaceutical and biotech industries, including clinical trials, post-marketing surveillance and long-term survival follow-up.
Albany, NY, April 12, 2014 --(PR.com)-- Transparency Market Research "Pharmacovigilance Market Clinical Trial Phases (Pre-Clinical Studies, Phase I, Phase II, Phase III, Phase IV or Post-Marketing Surveillance) and Service Providers (In-House and Contract Outsourcing) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019," the global pharmacovigilance market was valued at USD 2,147.3 million in 2012 and is estimated to reach a market worth USD 5,008.2 million in 2019 at a CAGR of 12.9% from 2013 to 2019.
* Post-marketing surveillance / Observational studies
A number of challenges can arise during post-marketing surveillance that can adversely affect a brand's position in the market.
Reportedly, the US FDA approval of Nasacort Allergy 24HR as an OTC treatment was 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 for Nasacort AQ.
PRA offers comprehensive services including the filing of Investigational New Drug and similar regulatory applications, management and implementation of Phase I through IV clinical trials, preparation and submission of New Drug Applications, and post-marketing surveillance on an international basis.
"Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market," said Sen.
When people don't have stroke symptoms, they are more likely to enroll in studies -- such as post-marketing surveillance -- that will cover the costs of the procedure, Gray told Reuters Health.
Extensive data involving over 70,000 patients in clinical studies, including randomized, controlled clinical trials that represent the gold standard of evidence, and the results of post-marketing surveillance arising from 24 million patient-years of clinical experience do not indicate an association between insulin glargine and cancer.
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