Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 24 January 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) released their strategic priorities for the coming year on 24 January 2012. The priorities consist of four main strategies and corresponding implementation goals, and includes several new and important initiatives.
CDRH's first strategy is to "fully implement a total product life cycle approach to product regulation that takes "into consideration all of the relevant information available to the Center" at "any stage of a product's life cycle."
To accomplish this, CDRH plans to:
CDRH's second strategy is to "enhance communication and transparency" in order to improve public health and generate constituent trust. CDRH plans to distribute information in a timelier manner, and by December 2012 start the development of a "national forum" to engage patient, consumers and healthcare professionals. CDRH also hopes to improve internal communications by issuing new SOP's for sharing information between CDRH staff and make general improvements.
CDRH's third strategy is to strengthen staff through a new Experiential Learning Program (ELP) and Leadership Enhancement and Development Program (LEAD) that should be fully implemented by the end of 2012. The agency is further looking to develop ways to recognize good employee performance and "address poor performance" in the agency.
The agency's fourth and final priority is to "facilitate innovation" to "address unmet public health needs." CDRH plans to do this by creating tools to improve the innovative products pipeline with the use of their Entrepreneurs in Residence Program and the piloting of a new Innovation Pathway 2.0. CDRH is further looking to develop guidance on companion diagnostics, draft guidance on co-development of drugs and biologics and devices, and new partnerships and virtual computer models to boost regulatory science.
Tags: Innovation Pathway, Goals, Strategic Priorities, Latest News, regulatory science, draft guidance, guidance