FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and offer the following steps to help smooth the process. The agency also offers a process for submitting sameple standardized datasets for validation. Sample submissions are tests only and not considered official submissions. They are not reviewed by FDA reviewers at any time. Follow the steps below to submit a sample.
For More Information please click here: FDA: Submit a Sample eCTD or Standardized Data Sample t Sample Submission Process
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