GESTIÓN EN SALUD PÚBLICA: FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

lunes, 20 de julio de 2020

FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

https://www.fda.gov/news-events/press-announcements/fda-extends-enforcement-discretion-policy-certain-regenerative-medicine-products?utm_campaign=072020_PR_FDA%20Extends%20Enforcement%20Discretion%20Policy%20for%20Certain%20Regenerative%20Medicine%20Products&utm_medium=email&utm_source=Eloqua

FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

Today, the U.S. Food and Drug Administration is extending the enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps). As a result of the challenges presented by the COVID-19 public health emergency, the FDA is extending its enforcement discretion policy which will provide manufacturers and potential sponsors an additional six months to determine if they need to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application, as appropriate.

The FDA’s November 2017 regenerative medicine policy framework was developed to help facilitate and support the innovation of regenerative medicine therapies. The agency also outlined its intent to exercise enforcement discretion, until November 2020, for certain regenerative medicine products, with respect to ...