What is Rolling Review?

Rolling Review is a process used by the US Food and Drug Administration (FDA) to expedite the review of new drug applications. Under this process, a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

The drugs which are granted Fast track Designation or Breakthrough Therapy Designation can be reviewed by Rolling Review procedure.