Search results
Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 6 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Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance | JD Supra
JD Supra· 6 days agoIn newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation ...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· 5 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 ...
FDA approves new tool to enhance cataract surgery outcomes
KTBS Shreveport· 7 days agoThe US Food and Drug Administration (FDA) has qualified the American Academy of Ophthalmology’s...
Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 2 days 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 ...
Conservative attacks on birth control could threaten access
Washington Post· 23 minutes agoRepublican lawmakers in Missouri blocked a bill to widen access to birth-control pills by falsely claiming they induce abortions. An antiabortion group in Louisiana killed legislation to enshrine ...
Exclusive: Former FDA official violated ethics rules by soliciting gifts from activists, watchdog...
BizPac Review· 20 hours agoProtect the Public’s Trust’s (PPT) complaint highlights emails showing that Kathy Crosby, who served in a high-level communications role at the FDA’s Center for Tobacco Products, accepted free ...
Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA
The National Law Review· 7 days agoThe less good news is that it appears, unless the Federal Food and Drug Administration approves...
Project 2025 Has Bad Medicine for HHS
The Nation· 1 day agoRoger Severino, a prominent attorney for the Christian right, led the Department of Health and Human Services’ Office of Civil Rights during the Trump ...
JD Supra: FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
JD Supra· 5 days agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial ...