Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

June 16, 2022

Computer generated rendering molecules, cells, and DNA structures.

Guidance Document

Draft Guidance for Industry

June 2022

This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards  (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate.  CBER encourages the use of appropriate standards in the development of CBER-regulated products.  The use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products.  This program is modeled after the formal standards and conformity assessment program or S-CAP for medical devices.

Download the Draft Guidance Document


Not for implementation.

Contains non-binding recommendations.

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.


Dose banding standard deviation graph.

July 21, 2022

Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”

Draft Guidance July 2022 This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application (NDA) submitted under the...

Hand holding a sign saying 'guidance.'

August 22, 2022

FDA Issues Revised Draft Guidance on Charging for Investigational Drugs Under an Investigational New Drug Application

August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on...

Circle with 'assess risk', 'control risk', 'review control', and 'identify risk' written encircling the 'risk management process.'

June 15, 2022

Q9(R1) Quality Risk Management

Guidance Document June 2022 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any...