FDA is Open to the Idea of Possible Regulatory Flexibility for Cell and Gene Therapies on a Case-by-Case Basis…Where Appropriate
January 13, 2026Yesterday, FDA announced “Flexible Requirements for Cell and Gene Therapies to Advance Innovation.” This regulatory flexibility, FDA hopes, will be “helpful in expediting product development and will help guide the FDA’s evaluation of development strategies in preparation for a Biologics License Application (BLA) submission.”
The announcement covers three broad areas: Clinical Development, Commercial Specifications, and Process Validation. It is important to note that this announcement is not the signaling of a new program or regulatory paradigm. The very general potential regulatory flexibilities are not new and have been extended to companies on an individual basis for years.
It is encouraging that CBER is appearing to make these potential flexibilities public and therefore increase the uniformity in which they are available to companies in the Cell and Gene Therapy space.
Hopefully, CBER will take a page out of CDER’s playbook and issue a public facing SOPP akin to the MAPP CDER has issued for expedited products under their purview “MAPP 5015.13 Quality Assessment for Products in Expedited Programs” (this author’s favorite MAPP).
We must wait and see if CBER follows-up on this announcement with specific guidance or direction that can expedite clinical development programs for this product area.