by Sarah Wesp | May 4, 2015
FDA releases new draft guidance in April 2015 entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drug. The purpose of this guidance is to make it easier for marketing...
by Sarah Wesp | Apr 28, 2015
Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not...
by Sarah Wesp | Apr 23, 2015
Pearl Pathways is pleased to announce that its President and CEO, Diana Caldwell, has been honored as the Center for Empowerment & Economic Development’s (CEED) Indiana Outstanding Achiever this year. This award is granted by CEED to individuals or organizations...
by Sarah Wesp | Apr 17, 2015
As of April 15, 2015, a year after its initial proposal, FDA will begin to accept applications to participate in its new accelerated review program. The program is intended for critical devices defined as, “devices that demonstrate the potential to address unmet...
by Sarah Wesp | Apr 13, 2015
As a sponsor of the 2014-2015 Indiana Life Sciences Collaboration Conference Series, Pearl Pathways would like to announce the upcoming conference entitled The Changing Role of the Consumer in Healthcare. We invite you to join us at the event on Friday, May 8th, where...