Zdrowie i gospodarka · 16/06/2022

FDA Announces Draft Guidance for Industry on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

The FDA is releasing a draft guidance for industry on a voluntary consensus standards recognition program for regenerative medicine therapies, aiming to facilitate the development and assessment of these therapies by identifying appropriate standards. This program is modeled after the formal standards and conformity assessment program for medical devices.