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4. **New Drug Application (NDA) or Premarket Approval (PMA)**: If the clinical trial results are positive, the company submits an NDA (for drugs) or PMA (for medical devices) to the FDA. This comprehensive application includes all the data collected during the clinical trials, as well as information about manufacturing processes, labeling, and proposed uses. The FDA reviews the application, which can take months to years, depending on the complexity of the product and the data submitted.
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