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3 Observations in Front Range Laboratory Inspection

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FDA releases the FDA-483 with three observations from an inspection at Front Range Laboratories.

Webinar on Drug QT/Proarrhythmic Risk Assessments

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FDA announces a two-day (10/15-16) public Webinar on New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk A...

High-Risk Groups Should Avoid Amalgam Fillings: FDA

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FDA says it now recommends that people in seven high-risk categories refrain from exposure to dental mercury amalgam when possible...

Safety Alert on Benadryl Overdoses

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Prompted by TikTok-posted teenager challenges, a new FDA safety alert warns that taking higher than recommended doses of Benadryl ...

Leap Therapeutics Fast Track for Gastric Cancer Drug

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FDA grants Leap Therapeutics a fast track designation for DKN-01 and its use in treating certain patients with gastric and gastroe...

$60 Million Surgical Mesh Agreement with 49 States

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A coalition of 49 state attorneys general reach agreement that requires C.R. Bard and its parent company, Becton, Dickinson, to pa...

Gilead Paying $97 Million in Letairis False Claims Case

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The Justice Department says Gilead is paying $97 million to resolve charges it illegally used a foundation to pay Medicare patient...

Final Rule, Guidance Issue on Drug Importation

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FDA and HHS announce a final rule that allows FDA-authorized programs to import certain prescription drugs from Canada if specific...

Novartis to Start AVXS-101 IT Confirmatory Study

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Novartis Gene Therapies says it will conduct an FDA-recommended pivotal confirmatory study of its AVXS-101 intrathecal formulation...

Court Says Private Plaintiffs Cant Second-Guess FDA

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Attorney James Beck says defense attorneys in FDA preemption cases would benefit from reading a recent North Carolina federal cour...