“[FDA] Information provided by an applicant for approval of a new type certificate (NTC) or amendment to an existing NTC.”


  • A major amendment is an amendment to an original submission, an efficacy submission, a manufacturing submission or a resubmitted version of any of these submissions that changes the length of time for which the FDA reviews the application.
  • An unsolicited amendment is any information or data submitted without having been asked for.

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Gustave Roussy
Beyond Spring
Clinical Services
NS Pharma
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