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Glucosamine Case Can Inform Drug, Device Cases: Attorney

Attorney Stephen McConnell explains how a recent court decision in a glucosamine supplement preemption case can be instructive to drug and medical dev...

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Human Drugs

GSKs Oral Anemia Drug Approved for Dialysis

FDA approves a GlaxoSmithKline NDA for Jesduvroq (daprodustat) tablet that it describes as the first oral treatment for anemia caused by chronic kidne...

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Human Drugs

Greenleaf Health Hires 2 Former FDA Officials

Regulatory consulting firm Greenleaf Health brings onboard two former FDA officials former Office of Compliance Don Ashley and former FDA Europe Offi...

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Human Drugs

FDA Warning, Import Alert on Contaminated Eyedrops

FDA issues an import alert and a safety alert on EzriCare Artificial Tears or Delsam Pharmas Artificial Tears due to potential bacterial contamination...

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Medical Devices

Philips BiPAP, CPAP Mask Recall is Class 1: FDA

FDA says the Philips Respironics recall of specified BiPAP and CPAP masks for a safety concern was Class 1

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Human Drugs

FDA Strategy on Opioid Reversal Products Nears Fruition

FDA outlines its ongoing strategy to expand access to overdose reversal products that has reached a milestone by having upcoming advisory committee me...

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Human Drugs

PMR/PMC Annual Statistical Report

FDA says most postmarketing reports and commitments are generally progessing on schedule, according to the FY 2021 annual report.

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Consider Mfg. Issues in Preparedness Planning: GAO

The Government Accountability Office says a new HHS program to produce medical countermeasures such as drugs and vaccines should assess challenges and...

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Marketing

GoodRx Paying $1.5 Million for Consumer Data Breach

The Federal Trade Commission says GoodRx will pay a $1.5 million civil penalty for failing to tell consumers and others about the unauthorized disclos...

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Ways to Mitigate Park Doctrine Risks: Attorney

Attorney Amanda Johnston explains five steps FDA-regulated company executives can take to mitigate the risk of Park Doctrine violations.