Clear and predictable regulations ensure that cell and gene therapy developers can navigate the regulatory process without unnecessary delays or uncertainty. ARM has been at the center of advancing new methods to bring cell and gene therapies to patients, such as championing the creation of the FDA’s RMAT Designation as a pathway to accelerate therapy development.
ARM supports and facilitates exchanges with the Office of Therapeutic Products through activities like horizon scanning for emerging technologies that will impact the sector and hosting webinars to educate staff on new topics affecting the sector.
ARM also regularly comments on FDA draft guidance to ensure it accounts for the sector’s perspectives.
