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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...
JD Supra: FDA's View on Cannabis
JD Supra· 1 day 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 misses own deadline to propose ban on cancer-linked formaldehyde from hair relaxers
TODAY via Yahoo News· 2 days agoThe FDA announced it would propose a ban on formaldehyde commonly found in hair relaxers typically...
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 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 developed tests ...
Orchard Software's Solutions Provide Support for Labs That Perform LDTs, Now Under FDA Oversight
The Pendulum· 23 hours agoIn response to the April 29th U.S. Food & Drug Administration (FDA) Final Rule 21 CFR Part 809...
FDA Finally Moves to Scrutinize Specialized Health Screenings
ProPublica· 4 days ago“This is a significant step forward,” said Peter Lurie, president and executive director of the...
Rare Pregnancy Problem Linked to Thiopurines, FDA Says
MedPage Today· 2 days agoUse of thiopurines has been linked with a rare risk of intrahepatic cholestasis of pregnancy (ICP),...
Apple Watch feature becomes first digital health tech to receive this FDA approval
Mashable· 2 days agoThe FDA just gave the Apple Watch a historic first approval for a digital health tech device....
Apple Watch is FDA's first-ever approved digital AFib history device
AppleInsider· 2 days agoThe FDA has approved the Apple Watch's atrial fibrillation history feature under its stringent...