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FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
JD Supra· 1 day agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal ...
Key Takeaways from FDA’s Final Rule on Laboratory-Developed Tests | JD Supra
JD Supra· 1 day agoThe US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests ...
The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs | JD Supra
JD Supra· 1 day agoOn May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs ...
Navigating the Regulatory Maze: Hemp Industry Calls for Additional Federal Action
The National Law Review· 16 hours agoYes, you read that correctly, and stakeholders are coalescing to push for action from the federal...
FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests | JD Supra
JD Supra· 1 day agoOn April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s ...
Thousands Believe Covid Vaccines Harmed Them. Is Anyone Listening?
New York Times· 5 days agoWithin minutes of getting the Johnson & Johnson Covid-19 vaccine, Michelle Zimmerman felt pain...
Georgia governor signs law adding regulations for production and sale of herbal supplement kratom
KTLA-TV Los Angeles· 6 days agoATLANTA (AP) — Georgia’s governor on Thursday signed a bill putting new regulations on the...
FDA Roundup: May 7, 2024
WPRI Providence· 17 hours agoToday, the FDA announced a meeting of the Psychopharmacologic Drugs Advisory Committee on June 4 to discuss a new drug application for midomafetamine (MDMA) capsules, submitted ...
...Disability Discrimination; FDA Finalizes LDT Rule; Senate Finance Committee Releases Drug...
JD Supra· 2 days agoOn April 29, 2024, the Food and Drug Administration (FDA) released a final rule entitled, Medical Devices; Laboratory ...
FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests | JD Supra
JD Supra· 2 days agoThe Food and Drug Administration (FDA) published its long-awaited Final Rule that will regulate laboratory developed ...