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Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 22 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 ...
Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 5 days agoThe group, whose members include Labcorp, Quest Diagnostics and multiple test developers, accused the FDA of regulatory overreach, in violation of the...
High Stakes: HHS Shakes Things Up on Marijuana Scheduling and DEA Abides | JD Supra
JD Supra· 4 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 ...
Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance | JD Supra
JD Supra· 5 days agoIn newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation ...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· 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 ...
FDA approves new tool to enhance cataract surgery outcomes
KTBS Shreveport· 6 days agoThe US Food and Drug Administration (FDA) has qualified the American Academy of Ophthalmology’s...
Federal and State Approaches to Therapeutic Cannabis | JD Supra
JD Supra· 6 days agoAt the federal level, the U.S. Food and Drug Administration (FDA) has approved one drug product ...
Nuts or Not Nuts? Second Circuit Declines to Consider Whether KIND’s Use of All-Natural Is...
The National Law Review· 6 days agoThe district court granted KIND’s motion for summary judgment in September 2022, holding that the...
CMS Updates IRA Landscape for Future Medicare Drug Price Negotiations | JD Supra
JD Supra· 6 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 ...
Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA
The National Law Review· 6 days agoThe less good news is that it appears, unless the Federal Food and Drug Administration approves...