FDA Speeds Up TB Test Approvals in Rule Tweak
Published Date: 3/30/2026
Proposed Rule
Summary
The FDA is planning to change the rules for certain tuberculosis (TB) tests, making them easier to get approved by moving them from a strict category to a more flexible one. This affects companies that make these TB immunity tests, helping speed up their review while keeping safety in check. Comments on this change are open until May 29, 2026, so stakeholders have time to weigh in before the new rules kick in.
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