Override: HHS Revokes FDA’s LDT Policies
The US department that oversees the FDA says the agency acted beyond its authority in asking labs to file emergency use authorizations, asserting that only CLIA rules should apply.
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Experts say either would likely prioritize issues such as the coronavirus pandemic and the medical supply chain, but they would diverge in areas like laboratory developed test reform.
Yes, Gottlieb’s in there twice; things get complicated when an agency starts to lose credibility.
The medical device advocacy group plans to include laboratory developed test reform in their upcoming user-fee negotiations with the US FDA.