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Clinical trial authorization application documentation

A Sponsor submits a clinical trial application to the Competent Authority in each member state where the trials are to be conducted. The Competent Authority has 60 days to review and approve or reject the application. Application is in prescribed forms and covers the proposed clinical trial protocol, manufacturing, and quality controls on the drug, and supporting data, such as (1) chemical, pharmaceutical, and biological data, (2) nonclinical pharmacological and toxicological data, and (3) clinical data and previous human experience. The supporting data are submitted in the Common Technical Document (CTD) format (see Section 7.11). [Pg.252]

Request for authorization to administer an investigational drug product to humans. INDs include structural formula, animal test results, and if available, prior human test results, manufacturing information, and the proposed clinical investigational plan. INDs must be submitted at least 30 days priorto the start of clinical trials FDA does not approved INDs but will notify applicants of issues within 30 days of receipt. The effective date of an IND is 30 days from the date of receipt by FDA s central document center unless a clinical... [Pg.39]


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