by Waylon Wright | Dec 21, 2021
This is the second of our “Ask the Expert” blogs, a series featuring the wisdom and seasoned insight of Pearl Pathways Advisors and Consultant Advisors. Members of the Quality and Regulatory Affairs team at Pearl Pathways were interviewed for this post. If you have...
by Waylon Wright | Nov 22, 2021
This is the first in a new series of “Ask the Expert” posts, which feature the wisdom and seasoned insight of Pearl Pathways Advisors and Consultant Advisors. First up is Bob Seevers, PhD, a former FDA reviewer and Consultant Advisor to Pearl Pathways with more than...
by Waylon Wright | Nov 22, 2021
One challenge to getting acclimated with the drug approval process is learning the language—especially the long list of acronyms, abbreviations, and unique terms that industry insiders use. As experienced advisors in this space, we at Pearl Pathways want to help those...
by Waylon Wright | Nov 16, 2021
The U.S. Food and Drug Administration’s (FDA’s) definitions of drugs and devices are remarkably similar—far more similar than you would think. Both are defined as products “intended for use in the diagnosis of disease or other conditions,” in the “cure, mitigation,...
by Waylon Wright | Mar 15, 2021
Robert Seevers, Senior Advisor at Pearl Pathways, will share insights during an Indiana Health Industry Forum (IHIF) webinar on Tuesday, March 16, 2021. The lunch event, “Pre-Clinical Pathways: Start Off On the Right Foot”, is part of IHIF’s...
