Drugs

Senator Introduces Regenerative Medicine Bill

Senator Tammy Baldwin (D-WI) has introduced a bill that would direct FDA to establish a public-private Standards Coordinating Body (SCB) for regenerative medicine. The Advancing Standards in Regenerative Medicine Act would also direct the agency to participate in developing such standards and to issue guidance on how these standards could be used in its review of regenerative medicine products.

“Regenerative medicine holds incredible potential to give us lifesaving therapies for serious diseases,” Baldwin said in a statement. “But, the lack of collaboration on standards development today is a huge obstacle as we work to boost the development of these advanced therapies.”

Regenerative medicines include cellular therapies, gene therapies, and tissue products. “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,” Baldwin said. “Regenerative medicine sponsors must show the FDA that products are safe and effective, including the ability to reliably and reproducibly manufacture products. This is a major challenge for products with the same biological activity. The more sophisticated the process, the greater the need for standardization, assay validation and harmonization. Coordinating basic standards are the first step to spurring innovators, getting more advanced therapies into the pipeline and into the hands of patients in need.”

Baldwin said the SCB’s primary mission would be to work with federal agencies, standards organizations, and other stakeholders to “create a central authority for the coordination, development support, communication and implementation of technical and process standards for the regenerative medicine industry.”

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FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome