Bill to Support the Development of Regenerative Medicine Introduced in Senate

On Tuesday, January 12, 2016, Senator Tammy Baldwin (D – WI) introduced the “Advancing Standards in Regenerative Medicine Act,” a bill supporting the development of regulatory science and the accompanying standards for regenerative medicine and other advancing therapies.

Regenerative medicines include cellular therapies, gene therapies, and tissue products, which “represent a growing field that holds the potential for more targeted medical treatments for chronic and life-threatening diseases.”

In a recent press release, Senator Baldwin claimed, if passed, that the bill “would direct the U.S. Food and Drug Administration (FDA) to facilitate the establishment of a public-private Standards Coordinating Body (SCB) in Regenerative Medicine.” The act would also allow FDA to participate in the development of related standards and to issue guidance on how the Agency could use those standards in the review of applicable products.

The press release stated that, in order “to help foster innovation and truly grow this evolving industry, stakeholders, researchers and the FDA need to come together on best practices, and basic technical and process standards.” Additionally, Baldwin also claimed that “both FDA and innovators will benefit by having standardized measurement processes from which to evaluate products.”

If you are in the process of developing a product that is considered a regenerative medicine or advancing therapy, we can help you achieve a successful interaction with FDA. For more information on our services and how can help you, contact us today.