Making All Data Count FDA Acceptance of nonUS Clinical Trials
FDA accepts data from non-US clinical trials for all stages of product development. Being able to use clinical data from a non-IND non-US clinical trial could greatly reduce the additional studies needed under an IND, thereby reducing the cost and time for developing a given product for the US market. It is even possible to rely solely on foreign clinical data as support for an IND or marketing approval application in the U.S. However, a non-IND/IDE clinical trial must meet several conditions before data generated in it can be acceptable for US applications. Recently, FDA released a new guidance document describing in great detail the many conditions a trial must meet before being acceptable to it.
The webinar, ‘Making All Data Count: FDA Acceptance of non-US Clinical Trials’, being conducted on 10-Dec-2013, will discuss the current FDA requirements for using clinical data from non-IND/IDE clinical trials in support of an IND and/or marketing approval application.
For more information about the webinar, please visit
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