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Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 12 hours agoOn May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug ...
High Stakes: HHS Shakes Things Up on Marijuana Scheduling and DEA Abides | JD Supra
JD Supra· 3 days agoOn May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from ...
Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 4 days 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Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance | JD Supra
JD Supra· 5 days agoIn newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation ...
Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | JD Supra
JD Supra· 6 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 ...
FDA approves new tool to enhance cataract surgery outcomes
KTBS Shreveport· 5 days agoThe US Food and Drug Administration (FDA) has qualified the American Academy of Ophthalmology’s...
CMS Updates IRA Landscape for Future Medicare Drug Price Negotiations | JD Supra
JD Supra· 5 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 ...
Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests | JD...
JD Supra· 7 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,...
Federal and State Approaches to Therapeutic Cannabis | JD Supra
JD Supra· 5 days agoAt the federal level, the U.S. Food and Drug Administration (FDA) has approved one drug product ...
Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA
The National Law Review· 5 days agoThe less good news is that it appears, unless the Federal Food and Drug Administration approves...