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: Thomas Sullivan Source Type: blogs
More News: Cardiology | Cardiovascular | Clinical Trials | Food and Drug Administration (FDA) | Health | Health Medicine & Bioethics Commentators | Heart | Men | Multiple Sclerosis | Partnerships | Polycystic Kidney Disease | Science | Statistics | Study | Toxicology | Training | Universities & Medical Training | Urology & Nephrology