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Steps for updating an mAb's availability and priority

Kaiming Tao edited this page Mar 4, 2022 · 1 revision

The availability of a monoclonal antibody (mAb) changes when the mAb is 1) entering next phase of clinical trials; 2) being granted permission or EUA by US FDA; 3) being granted permission by a major country government (CN, EU, or UK). Here listed steps need to be taken for updating an mAb's availability status in DRDB:

  1. Update following columns of antibodies.csv:
    Column Value
    availability "EUA" if granted EUA by FDA
    "Approved" if approved by FDA
    "XX-Approved" if approved by a major country government (e.g. CN-Approved, EU-Approved, etc.)
    Phase 1/2/3 for in clinical trials
    priority ranking order: FDA approved (priority<50)
    EUA approved (priority<50)
    non-US approved (priority<50)
    phase 3 (priority between 50 to 500)
    phase 2 (priority between 50 to 500)
    phase 1 (priority between 50 to 500)
    visibility TRUE for "Approved", "EUA" and "XX-Approved".
    Case by case decision required for "Phase 1/2/3".
  2. Update the mAb description. For example: hivdb/chiro-cms@28f3b41.