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FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices
The National Law Review· 3 days agoOn April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule...
FDA Says It Will Take on Wider Regulation of Medical Tests. Is It Ready?
Bloomberg· 1 day agoHi, it’s John in Boston. This week, the FDA signaled it may finally make a move that’s been on the...
A Sea Change Looms as FDA Finalizes Its Controversial Regulation Asserting Jurisdiction Over LDTs |...
JD Supra· 3 days ago...after years of false starts trying to expand oversight of laboratory developed tests (“LDTs”) through administrative and legislative actions, FDA announced the much-anticipated—and highly controversial—final rule, Medical Devices; Laboratory Developed...The rule asserts jurisdiction over LDTs...
FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In...
JD Supra· 2 days agoOn April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory ...
Senate vape regulation bill goes up in smoke, House version still breathing
McComb Enterprise-Journal· 21 minutes agoA Senate bill that would have prevented the sale of vape products in Mississippi that are not approved by the federal Food and Drug Administration (FDA) died in conference ...
FDA finalizes lab test regulations with more flexibility
Politico· 4 days agoChief among them is a grandfathering clause which means the FDA will “generally not enforce” premarket review and quality systems requirements for currently marketed tests ...
FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
The National Law Review· 4 days agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and...
FDA Issues Final Rule on Regulation of Laboratory Developed Tests | JD Supra
JD Supra· 4 days agoThis final ruling amends the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs), including those manufactured by laboratories, ...
JD Supra: FDA's View on Cannabis
JD Supra· 18 hours agoThe U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first ...
FDA Roundup: May 03, 2024
CW39 NewsFix· 15 hours agoToday, the FDA announced the availability of draft guidance for industry (GFI) #290 (VICH GL61) entitled "Pharmaceutical Development" for veterinary drug products. This draft ...
