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FDA leaders talk adcomms, shortages
Politico· 19 hours ago“We strongly support state and federal regulators taking action to deter and punish compounding pharmacies, counterfeiters, and others who put patients at risk by selling ...
Merus Carcinoma Treatment Awarded US FDA's Breakthrough Therapy Designation
Morningstar· 5 days agoBy Dean Seal Merus said federal regulators have granted breakthrough therapy designation to its carcinoma treatment petosemtamab. The clinical-stage oncology company said ...
Recalls Up 8% in Q1 as Regulators Ramp Up Product Safety Oversight - Risk & Insurance
Risk & Insurance· 17 hours agoRecall Index report from Sedgwick. The report found recalls increased 8% quarter-over-quarter to 909...
Delta-8 THC is legal in Oklahoma. But is it safe? FDA gives warning
The Oklahoman via Yahoo News· 3 days agoPatrick Cournoyer leads the FDA’s cannabis product committee. He told USA TODAY the prevalence of...
Surge in Social Media Drug Promotion Driving Calls for More Oversight | Corporate Counsel
Law.com· 15 hours agoWhether demands from some in the medical community and in Congress will spur new FDA guidance and greater enforcement, FDA-regulated companies should consider ...
EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology | JD Supra
JD Supra· 1 day agoFood and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline... Coordinated Framework for the Regulation of Biotechnology ...
Lilly settles with spa selling knockoff versions of its popular diabetes, weight-loss drugs -...
Indianapolis Business Journal· 3 days agoEli Lilly and Co. has entered a settlement agreement with a South Carolina medical spa that was...
JD Supra: FDA Charts Course for Regulating AI Used in Medical Products
JD Supra· 7 days agoThe paper was issued by the FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological ...
EPA, USDA, and FDA to Clarify Overlapping Biotechnology Regulatory Frameworks | JD Supra
JD Supra· 4 days agoEnvironmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) released a joint plan to identify areas of ambiguity ...
Patent Peril: 3 Stocks at Risk From the FTC's Drug Crusade
InvestorPlace· 2 days agoSeveral drug stocks are at risk as the Federal Trade Commission is going after pharmaceutical...