Based on type of clinical trial phases, the market is categorized in to preclinical studies, phase I, II, III, IV or post-marketing surveillance
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:
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
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