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JD Supra: FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
JD Supra· 3 hours agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial ...
Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 1 day agoThe group, whose members include Labcorp, Quest Diagnostics and multiple test developers, accused the FDA of regulatory overreach, in violation of the...
FDA approves new tool to enhance cataract surgery outcomes
Medical Device Network via Yahoo Finance· 5 days agoThe US Food and Drug Administration (FDA) has qualified the American Academy of Ophthalmology's...
Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance | JD Supra
JD Supra· 2 days agoIn newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation ...
High Stakes: HHS Shakes Things Up on Marijuana Scheduling and DEA Abides | JD Supra
JD Supra· 16 hours agoOn May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from ...
Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | JD Supra
JD Supra· 4 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 ...
DOJ Proposes to Reschedule Marijuana (Cannabis) To Schedule III
The National Law Review· 8 hours agoFollowing a comprehensive review by the US Department of Health and Humans Services (HHS) on cannabis’s safety and subsequent recommendation to the < ...
Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests | JD...
JD Supra· 4 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· 3 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· 2 days agoThe less good news is that it appears, unless the Federal Food and Drug Administration approves...
