According to Alexander Gaffney of, FDA has finalized the guidance document regarding its four expedited drug approval programs: fast track designation, priority review designation, accelerated approval, and breakthrough product designation. These four programs are designed for drugs that are intended to treat serious or life-threatening conditions.

Following the release of the draft guidance supporting these programs, FDA received numerous comments and suggestions from industry representatives, which resulted in hundreds of changes to the final document. Some of these changes highlighted in the article include:

  • FDA has committed to rolling reviews for some breakthrough products as well as grant breakthrough products access to priority review.
  • Clarification that just because FDA grants a product breakthrough therapy designation, this doesn’t mean it will obtain approval.
  • A new definition for the term preliminary clinical evidence: “evidence that is sufficient to indicate that the drug may demonstrate substantial improvement in effectiveness or safety over available therapies, but in most cases is not sufficient to establish safety and effectiveness for purposes of approval.”

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