FDA: Partnerships to Accelerate Medical Product Development

Discussion of Key Initiatives/Activities and Outcomes Joint liaisons to key initiatives PSTC and SAFE-T Consortium Remove Redundancy--Proactive sharing of strategy and plans Build Collaborative IT Platforms  Garner then discussed how FDA and stakeholders should measure success with these new collaborations.  She said that FDA will measure success based on:  The number of approvals of new medical therapies Development of new guidance Integration of novel biomarkers into regulatory review processes Proactive sharing of pre-competitive data Development of data warehouses based on standardized data in order to leverage prior knowledge Streamlined coordination of information among international regulators  In mentioning current and previous success, Garner pointed to the number of drug approvals in 2012.  Through Nov 30, in Calendar Year (CY) 2012, CDER had received 34 NME applications.   Ultimately, Garner proposed that FDA and stakeholders “create collaborative platforms which provide a global mapping of Public Private Partnership (PPP) activities. Such activities would have an Internal aspect, which allows an interface for PPPs to collaborate and share information safely, as well as an external aspect, which allows potential stakeholders to identify efforts to support.  Garner said that the benefits from such a proposal will allow PPPs to identify current efforts for collaboration internationally and target gaps for future development.
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs