Pearls of Wisdom
Ask the Expert: What Does FDA Want to Hear From Drug Developers?
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...
Get Up to Speed on the ABCs of Global Regulatory Filings
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...
Is Your Drug a Device? Or Vice Versa?
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,...
FDA Grants Marketing Authorization of First SARS-CoV-2 Diagnostic Test Using the De Novo Review Pathway
On March 17th, 2021, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) using the De Novo premarket review pathway. The BioFire RP 2.1 is a diagnostic test for the simultaneous qualitative detection...
But Wait, There’s More!
Remember those TV commercials that featured a product and touted its wonderful properties, only to continue with, “But wait! There’s more!”? Sometimes, I feel like that about the services that Pearl Pathways offers. Pearl Pathways is all about accelerating product...