Newsletter - November 18, 2021
FDA’s EUA for Covid LDTs Has Minimal Impact on Most LDTs
This week FDA announced that it is going to require emergency use authorizations (EUA) for Lab Developed Tests (LDTs) intended for Covid diagnosis summarily reversing a decision last August that LDTs don’t need EUA. While this may seem like a major decision, it is not. The announcement is very specific to RT-PCR tests for Covid...Read More
The Revolving Door Turns a Full 360 degrees with Califf: Why Should We Care?
Does it matter that the FDA’s top leader has cozy relationships with the industry he regulates? Would it influence the policies he proposes, and would those policies still give patient and public interest the same weight as that of the for-profit industry? These are reasonable questions to ask when anyone takes on...Read More
FDA’s EUA for Covid LDTs Has Minimal Impact on Most LDTs
This week FDA announced that it is going to require emergency use authorizations (EUA) for Lab Developed Tests (LDTs) intended for Covid diagnosis summarily reversing a decision last August that LDTs don’t need EUA. While this may seem like a major decision, it is not. The announcement is very specific to RT-PCR tests for Covid...Read More
The Revolving Door Turns a Full 360 degrees with Califf: Why Should We Care?
Does it matter that the FDA’s top leader has cozy relationships with the industry he regulates? Would it influence the policies he proposes, and would those policies still give patient and public interest the same weight as that of the for-profit industry? These are reasonable questions to ask when anyone takes on...Read More
