“[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.
- 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.
- Unsolicited Amendment – a submission of information or data not requested by the Agency.”
Source: SOPP 8401.2: Administrative Processing of BLA and NDA Supplements
