Pearls of Wisdom
Pre-Clinical Pathways: Start Off On the Right Foot – Robert Seevers will speak during IHIF Life Sciences Lunch webinar
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 recurring Life Sciences...
FDA rolls out permanent 510(k) exemptions for several medical devices
In response to the Covid-19 Public Health Emergency, the U.S. Food and Drug Administration (FDA) permanently exempted seven Class I device types from 510(k) premarket notification requirements. FDA also proposed similar exemptions for 83 Class II devices and one...
You Have a Friend at the FDA – No, Really
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...
FDA revamps intended use rule
The new rule on intended use has been updated by the US Food and Drug Administration (FDA) and would repeal and replace previous portions of the earlier final rule. The updated rule (21 CFR 201.128 and 801.4) was published during September 2020. The delays in...
In Search of the Perfect IND
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 perfect IND...