FDA in the Time of Coronavirus: Understanding the New VALID Act with Turna Ray, GenomeWeb


Turna Ray, Managing Editor, Precision Oncology News, GenomeWeb

Bio and Contact Info

Chapters:

0:00 What is the new VALID bill about?

5:48 Is this odd timing?

13:30 Why was the CDC was so slow with testing?

14:42 State of COVID-19 testing

20:45 Will at-home tests happen?

28:25 Is regular Dx business rolling again?

After the virus reached American shores, was the FDA quick enough to allow companies and labs to develop their own tests without restrictive oversight? The question sparked a sweeping new bill in congress, the VALID Act that could overhaul FDA oversight of diagnostics altogether—something that has been clamored for for a generation.

Turna Ray has been covering the FDA and diagnostics for GenomeWeb since 2006. She has recently written a piece on the new VALID Act that includes responses from various members of the community.

As Turna says in her piece, now could be an odd time for Congress to be putting through such important legislation regarding FDA’s oversight of diagnostics and LDTs with everyone in crisis mode. It could be an appropriate time as well. As one community member told Turna:

“Historically it often takes a big public health catastrophe to change the regulatory system for medical products."

What is the general state of testing today? Why was the CDC so slow? Will at-home tests happen? Turna covers all of this in her interview.



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