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Is a biennial report the same as an annual report?
While nearly every state requires information reports to be filed periodically, not all require that information to be filed annually. Some states have biennial reports (due every other year) instead. Whether annual or biennial, the purpose of a companys annual report remains the same.
How long should DSUR be submitted?
Sponsors are required to submit a DSUR within one year of the Development International Birth Date (DIBD the date of first authorisation of a clinical trial in any country worldwide) and provide annual DSUR submissions until all open clinical studies have ended (the final clinical study is completed and its study
Which FDA submission requires an annual report?
For clinical trials being conducted under an IND, FDA requires an annual report from the Sponsor or Sponsor-Investigator. The annual report is due within 60 days of the anniversary date that the IND went effect (i.e., the date that the FDA permitted the study to begin).
Is DSUR the same as an annual report?
What Are the Differences Between the FDA DSUR Requirements and the IND Annual Report? The FDA anticipates that the proposed annual FDA DSUR will retain the general aspects of the current IND annual report but will include more comprehensive information.
What is the DSUR format FDA?
The DSUR is a cross-functional document summarizing information from non‑clinical, clinical, and pharmacovigilance experts in an exercise specifically focused on identifying risks and their mitigation. Thus, the format is aligned with the FDAs focus on benefit-risk in the assessment of new drugs.
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People also ask
What is a DSUR?
A Development Safety Update Report (DSUR) gives safety information relating to drugs under clinical development.
What is an annual report called?
Annual reports (also called a form 10K by the SEC) typically include the following: A letter from the Chairman of the Board to the shareholders. Financial statements including sales, stock, and marketing data. Information about products and subsidiaries. A list of directors and officers of the company.
Related links
HJ CRO International - Verify.Wiki
HJ CRO International, Inc., is a premier full service Clinical Research Organization (CRO) offering global clinical trial solutions.
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