• Regulatory NewsRegulatory News

    FDA explains plans to bolster cell and gene therapy approvals through wider messaging

    Updated 25 May 2022 to correct ASGCT's name. Wilson Bryan director of the US Food and Drug Administration’s Office of Tissues and Advanced Therapies (OTA) in the agency’s Center for Biologics Evaluation and Research, told a 19 May meeting  of the American Society of Gene and Cell Therapy (ASGCT) that the division is undertaking a series of internal measures to improve communications with sponsors and to widen its messaging.   These measures are being taken to com...
  • Regulatory NewsRegulatory News

    FDA Begins Accepting Regenerative Therapy Applications for RAT Designation

    The US Food and Drug Administration (FDA) on Thursday unveiled a new designation category created as part of the 21st Century Cures Act to allow drugs to be eligible for designation as a regenerative advanced therapy (RAT). The stipulations for such a RAT designation include: “The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such the...
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    FDA’s CBER Restructures and Creates New Office of Tissues and Advanced Therapies

    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...