New FDA Bill Bypasses LDTs Reform—Again
It now appears that Congress is going to dash the lab industry’s hopes yet again by reauthorizing FDA user fees without VALID.
LDTs Legislation Inches Closer to Passage, but Major Hurdles Remain
The VALID Act for FDA regulation of laboratory developed tests is working its way through the final stages of the legislative process, but not everyone is loving it.
CDC, Major Laboratory Companies Launch New Tests for Monkeypox
As the outbreak continues to grow in countries that have not historically seen monkeypox cases, testing companies are stepping up.
Bill to Regulate LDTs Advances, but Is No Slam Dunk for Final Passage
Now that the finishing touches have been put on LDT-related legislation, what is the likelihood that it will pass?
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Laboratory Developed Test Regulatory Reform Moves Closer to Reality
Newly proposed legislation would establish a risk-based regulatory system for LDT regulation, though not everyone is happy with it.
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