Development safety update reports

The DSUR is not submitted as part of your CTA since by definition the DSUR is prepared per active substance and will contain data pertinent to all dosage forms and strengths, all indications, and all patient populations under study with the investigational product during the reporting period. If requested, you should be able to quickly provide the most current DSUR.

Cervical Health Awareness Month is a good time to review the state of cervical cancer, what you can do personally, Skip to content. By Amelie Rodrigue-Way, Ph. The objectives of DSUR review at Health Canada are as follows: Enhance the safety surveillance of drugs in development and protect clinical trial subjects; Analyze important identified and potential risks; Identify potential safety issues at the pre-approval stage; Support, when required, the safety assessment of drugs submitted for market authorization; and Support the life cycle approach to product vigilance.

The DSUR is a more or less harmonized document now accepted in most of the countries of the world. It is a more complex and analytical document than the old style annual safety reports. Very informative.!! Is it required to submit for indian companies? The report should clarify whether the trial is ongoing, completed, or terminated. In case of termination, detailed reasons for such termination must be communicated to the DCGI within 30 working days of the termination.

Montelukast: Risk Of Neuropsychiatric Reactions. What is a DSUR? DSUR for single active moiety and combined products: A single DSUR including safety data from all clinical trials conducted with the drug should be prepared for an investigational drug: All indications All dosage forms All intended populations For combined products: A single DSUR should be prepared for clinical trials involving a fixed combination product i.

The DSUR includes safety information of active moiety from: All ongoing clinical trials and other studies that the sponsor is conducting or has completed during the review period Observational or epidemiological studies Nonclinical studies toxicological and in vitro studies Related DSURs, if applicable to the investigational drug Manufacturing or microbiological changes Studies recently published in the literature Clinical trials with results indicating lack of efficacy that could have a direct impact on subject safety e.

Safety Findings from Noninterventional Studies Safety Findings from Marketing Experience Nonclinical Data Leave this field blank. I'm a spammer. Current effective version. Reference number. Effective from. Development safety update report DSUR , active substance , periodicity, data lock point, combination therapies, reference safety information, clinical trials , cumulative subject exposure, line listings, new safety data, non-clinical data, literature, lack of efficacy , late-breaking information, benefit-risk.