Efficacy Supplement

[FDA] A supplement to an approved application proposing to make one or more related changes from among the following changes to product labeling:

  • Add or modify an indication or claim;
  • Revise the dose or dose regimen;
  • Provide for a new route of administration;
  • Make a comparative efficacy claim naming another drug product;
  • Significantly alter the intended patient population;
  • Incorporate other information based on at least one adequate and wellcontrolled clinical study.

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


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