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Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 20 hours agoThe group, whose members include Labcorp, Quest Diagnostics and multiple test developers, accused the FDA of regulatory overreach, in violation of the...
Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance | JD Supra
JD Supra· 1 day agoIn newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation ...
FDA approves new tool to enhance cataract surgery outcomes
Medical Device Network via Yahoo Finance· 4 days agoThe US Food and Drug Administration (FDA) has qualified the American Academy of Ophthalmology's...
Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | JD Supra
JD Supra· 3 days agoThe U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will ...
Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA
The National Law Review· 2 days agoThe less good news is that it appears, unless the Federal Food and Drug Administration approves...
Federal and State Approaches to Therapeutic Cannabis | JD Supra
JD Supra· 2 days agoAt the federal level, the U.S. Food and Drug Administration (FDA) has approved one drug product ...
Amendment killing nationally legal cannabis makes it into House farm bill
The Hill via Yahoo News· 6 days agoA ban on intoxicating hemp products has made it into the House version of the farm bill. If the...
Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests | JD...
JD Supra· 3 days agoThe U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years,...
Fact Check: We Looked Into the Claim that Breyer's Ice Cream Is Now Called 'Frozen Dessert' Because...
Snopes· 6 days agoThe U.S. Food and Drug Administration requires that commercially produced ice cream weigh at least...
CMS Updates IRA Landscape for Future Medicare Drug Price Negotiations | JD Supra
JD Supra· 2 days agoThe program—established by the Inflation Reduction Act and currently in active negotiations with manufacturers of the first 10 drugs selected for initial applicability year ...