FDA Prepares To Regulate LDTs, One Way Or The Other
US FDA officials have said multiple times that they plan to move to regulate lab-developed tests, with or without Congressional action. And this week, the agency made a formal announcement of those intentions via the Unified Agenda.
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The VALID Act, which will hand diagnostics oversight to the US FDA, has been reintroduced in the House of Representatives after it failed twice last year in Congress.
During a recent webinar hosted by the Alliance for a Stronger FDA, Elizabeth Hillebrenner, associate director for scientific and regulatory programs at the agency’s device center, vowed to keep fighting for diagnostic reform despite Congress failing to pass the VALID Act last year.
Robert Califf marked his one-year anniversary as the commissioner of the US Food and Drug Administration by discussing the first year of his second term as the agency’s chief executive and his vision for the future.