by Katie Oakley | Jun 23, 2014
Pearl Pathways is pleased to announce the recent hiring of Heidi Hancock Strunk, RAC as a Regulatory Compliance Advisor. Strunk brings over twenty-three years of experience in FDA-regulated industries and thirteen years in management, including extensive expertise in...
by Katie Oakley | Jun 19, 2014
We are pleased to announce our recent updates to the Resources section of the Pearl IRB website, where you will find new and revised forms to serve you in the IRB submission process. Some of these changes include: Updated submission guide and policies, which we...
by Katie Oakley | Jun 18, 2014
According to Alexander Gaffney of RAPS.org, FDA has finalized the guidance document regarding its four expedited drug approval programs: fast track designation, priority review designation, accelerated approval, and breakthrough product designation. These four...
by Katie Oakley | Jun 16, 2014
There’s an app for just about everything, but how do you know which one to trust? There are nearly 80,000 medical apps available to the public; however, very few are tested and regulated by FDA, according to Varun Saxena’s article on fiercemedicaldevices.com. As a...
by Katie Oakley | Jun 16, 2014
FDA has launched openFDA, a new “digital strategy” initiative intended to make government data and information more publicly accessible as covered by Alexander Gaffney of RAPS.org. The initiative began in January 2014 with the introduction of open.fda.gov, a website...
