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FDA sets date for advisory meeting on Lilly’s closely watched Alzheimer’s drug
BioPharma Dive via Yahoo Finance· 7 hours agoBut in early March, Lilly said the decision deadline would be pushed back because of the FDA’s plans...
US FDA panel to discuss Eli Lilly Alzheimer's drug on June 10
Reuters via Yahoo News· 4 hours agoFood and Drug Administration's approval last year. Lilly's donanemab was declined accelerated...
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
The National Law Review· 1 day agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs)...
FDA Finalizes Rule Regulating Laboratory Developed Tests
The National Law Review· 1 day agoFDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal...
RapidAI’s AngioFlow imaging solution gains FDA 510(k) clearance
Medical Device Network via Yahoo Finance· 10 hours agoRapidAI has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its...
Key Takeaways from FDA’s Final Rule on Laboratory-Developed Tests | JD Supra
JD Supra· 11 hours agoThis marks the beginning of the end of FDA’s broad and long-established enforcement discretion policy for LDTs, under which most LDTs were not expected to meet the premarket ...
Recall: Planters Honey Roasted Peanuts, Mixed Nuts Potentially Contaminated with Listeria
Health via Yahoo News· 20 hours agoThe two recalled Planters products were shipped to certain Publix and Dollar Tree distribution...
FDA under fire: Pared-down LDT Final Rule leaves unanswered questions | JD Supra
JD Supra· 11 hours agoFDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR § 809.3 to make explicit that IVDs are medical ...
The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs | JD Supra
JD Supra· 11 hours agoOn May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision ...
Earnings call: Owlet reports robust Q1 2024 financial growth, FDA clearance By Investing.com
Investing.com· 9 hours agoOwlet Baby Care, Inc. (ticker: OWLT) has announced significant financial growth in the first quarter...
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