“[FDA] Information submitted to a pending submission, including additional information or reanalysis of data previously submitted to clarify, revise or modify the application as originally submitted.

  1. Major Amendment – an amendment to an original application, efficacy supplement, manufacturing supplement or resubmission of any of these applications, including biosimilars, that extends the review clock.
  2. Unsolicited Amendment – a submission of information or data not requested by the Agency.”

Source: SOPP 8401.2: Administrative Processing of BLA and NDA Supplements


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