by Robert Seevers | Mar 26, 2021
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...
by Robert Seevers | Jan 25, 2021
Did you know that you have a friend at the U.S. Food & Drug Association (FDA)? Someone who ensures that interactions with the regulators go well and that results are communicated to you promptly and efficiently. Someone who works very hard to coordinate reviews of...
by Robert Seevers | Jul 20, 2020
A recent initial investigational new drug (IND) submission that Pearl Pathways prepared for a client caused me to think about the “perfect” IND. How might one define a perfect IND? In a previous job I held, there was a company Vice President who thought a...
by Robert Seevers | Apr 16, 2020
The United States Food and Drug Administration has taken a beating in recent weeks over its role in the country’s efforts to combat the COVID-19 virus. The concerns have been focused on two basic areas:delays in approving tests for use in diagnosing the virus and for...
by Robert Seevers | Mar 20, 2020
You have just been told by a regulatory consultant or trusted advisor that you have to perform a particular study to get your drug or device clinical trial or marketing application approved. And then you ask yourself, “Where does it say that I have to do that?” As...
