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Compliance In Focus

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LEARN MORE ABOUT REMOTE SERVICES

Keep Your Clinical Trial Moving from a Distance

You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.

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Posted by John Lehmann on Wed, Mar 04, 2015

CDRH’s 2014/2015 Strategic Priorities

On February 5th, the CDRH released its strategic priorities for 2014 and 2015.  This is the first time the device center has released a two-year strategic plan rather than an annual plan.  The center is focusing on strengthening the clinical trial enterprise, striking the right balance between pre-market and post-market data collection, and providing excellent customer service.

Topics: Center for Devices and Radiological Health, Strategic Priorities, Jeffrey Shuren

Posted by Jacqui Lingler on Fri, Jun 03, 2016

Entrepreneurs-in-Residence Program - Take 2!

The Entrepreneurs-in-Residence Program (EIR), a program at the Center for Devices and Radiological Health (CDRH), brings entrepreneurs, innovators, and government employees to combine the principles of lean engineering in rapidly testing, validating and scaling new approaches to the development in areas that impact innovation with the goal of delivering transformational change. This change, specifically in the medical device arena of public heath, would provide patients in the U.S. to high-quality, safe, and effective devices quicker.

Topics: Center for Devices and Radiological Health, Entrepreneurs-in-Residence Program, Clinical Research

Posted by John Lehmann on Wed, Mar 04, 2015

FDA’s To-Do List 2013 - PART I

The CDRH (Center for Devices and Radiological Health) recently released their annual proposed Guidance development document for the upcoming fiscal year. This provides an overview of the intended guidance documents FDA plans to fully publish, and those documents FDA hopes to publish.

Topics: To-Do List, Center for Devices and Radiological Health, Medical Device User Fee Act, FDA