FDA’s CBER Restructures and Creates New Office of Tissues and Advanced Therapies

Regulatory NewsRegulatory News | 19 October 2016 |  By 

The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on Wednesday announced that it will restructure after an internal review and create a new Office of Tissues and Advanced Therapies (OTAT), which was formerly known as the Office of Cellular, Tissue and Gene Therapies (OCTGT).

According to an agency announcement, senior CBER leadership evaluated a variety of alternatives that would allow the center to more efficiently accomplish its regulatory mission.

CBER spokesman Paul Richards told Focus: "CBER is in the process of recruiting to fill the office director position vacated by Celia Witten, PhD, MD upon her selection as Deputy Director for the Center. In addition to this vacancy (for the director of the Office of Tissues and Advanced Therapies, formerly OCTGT), other managerial appointments and/or shifts within the office may occur.  Further information regarding the office structure will be posted on CBER’s web site once it becomes available." 

The new CBER structure, which became effective 16 October, includes the Office of Blood Research and Review (OBRR), the Office of Vaccines Research and Review (OVRR) and OTAT.

“The formation of OTAT involves the transfer of OBRR’s Division of Hematology Clinical Review and Division of Hematology Research and Review, along with appropriate support staff, to OCTGT to constitute the new office. The products now regulated by OTAT include all purified and recombinant versions of therapeutic proteins for hematology.  Antivenins have also been transferred to OTAT,” the announcement said.

CBER added that the restructuring should not have a significant impact on the review of pending applications, and the center anticipates meeting its user fee obligations, including performance goals, during this transition.


Editor's note: Article updated on 10/20 with comment from FDA.


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