Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
June 16, 2022
Draft Guidance for Industry
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.
FDA Issues Revised Draft Guidance on Charging for Investigational Drugs Under an Investigational New Drug Application
August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s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...