Blog
RSS FeedPosted by Michael Wonder on 21 May 2019
Framework for the regulation of regenerative medicine products
21 May 2019 - The U.S. FDA has published four final guidance documents that are part of a comprehensive policy framework ...
Posted by Michael Wonder on 19 Dec 2018
Comparative assessment of clinical benefit using the ESMO Magnitude of Clinical Benefit Scale version 1.1 and the ASCO Value Framework Net Health Benefit Score
19 December 2018 - To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) ...
Posted by Michael Wonder on 16 Nov 2017
Statement from FDA Commissioner on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
16 November 2017 - One of the most promising fields of science is the area of cell-based therapies and their ...
Posted by Michael Wonder on 07 Sep 2017
FDA’s plan to engage the public in the agency’s new effort to strengthen and modernise FDA’s regulatory framework
7 September 2017 - We’re at a moment of extraordinary opportunity to improve the public health. New innovations are giving us ...
Posted by Michael Wonder on 30 Jun 2016
Strengthening interaction with academia
30 June 2016 - EMA consults academia in preparation of a framework of collaboration. ...