Biologics

Regenerative Medicine Consensus Standards Guide

FDA has published a guidance, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies, describing a CBER program to identify and recognize voluntary consensus standards (VCS) to facilitate the development and assessment of regenerative medicine therapy products when such standards are appropriate. The document says CBER encourages the use of appropriate standards in the development of Center-regulated products.

“The use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for regenerative medicine therapy products,” the guidance says. “This program is modeled after the formal standards and conformity assessment program for medical devices.”

The guidance includes an Introduction, Background, Scope, Purpose of the Program, Procedures for Evaluating VCS for Recognition in the SRP-RMT (standards recognition program-regenerative medicine therapy), Documenting the Use of a Standard Recognized by CBER Under the SRP-RMT in a Regulatory Submission, Questions and Answers, Paperwork Reduction Act of 1995, References, and Appendices.

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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