In major news released today, the Office of U.S. Senator for Illinois, Mark Kirk, announced the introduction of The REGROW Act, a bill designed to “reduce barriers to medical innovation and accelerate the development of new regenerative medicine treatments.”

The legislation could substantially support stem cell innovation, as it requires the “FDA to collaborate with stakeholders to develop standards that will lead to manufacturing processes and controls for safe regenerative medicine products.”

The ability of stakeholders to work collaboratively with the FDA has been a major hot topic lately, with a FDA Public Hearing to review four draft guidances controlling the regulation of stem cells recently postponed due to an unexpectedly large number of registrations (approximately 600). It is my opinion – and one that is shared by most advocacy groups – that the large turn-out for this FDA public hearing was a successful effort to communicate patient concerns to the FDA and a way to indicate that more input is needed in the regulatory process.

Most impressively, the REGROW Act is supported by leading groups within the regenerative medicine space, including: [Read more…]