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FDA Strategy on Opioid Reversal Products Nears Fruition

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

PMR/PMC Annual Statistical Report

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

Consider Mfg. Issues in Preparedness Planning: GAO

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

GoodRx Paying $1.5 Million for Consumer Data Breach

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

Ways to Mitigate Park Doctrine Risks: Attorney

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

Expanded Indication for Abbott Heart Catheter

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FDA approves an expanded ventricular tachycardia indication for Abbotts FlexAbility catheter.

Fraudulent Contract Research Org. Leads to Debarment

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Federal Register notice: FDA issues debarment order against Sami Anwar that bars him from providing services related to an approve...

Glucosamine Case Can Inform Drug, Device Cases: Attorney

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

M13A Bioequivalence Consensus Guideline

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FDA publishes the International Council on Harmonization M13A guidance on bioequivalence for immediate-release solid oral dosage f...

Positive Covid Test Requirement Lifted on 2 Therapeutics

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FDA says two Covid-19 therapeutics can now be prescribed without having a positive test result showing Covid-19 infection when a p...