At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA ...
This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the ...
After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.
A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...
Increased supervision of genetic testing is needed to ensure the usefulness of the increasingly popular tests, often promoted as a way to personalize medical treatment, a U.S. government draft report ...
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