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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes AkivaMed, Oxford Medical Instruments and SilveryGuy.

Feds Charge Teva with Illegal Copaxone Kickbacks

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The Justice Department charges Teva with paying illegal kickbacks by funding foundations to channel company money to pay Medicare ...

Priority Review for Alternative Imfinzi Dosing

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FDA grants AstraZeneca a priority review for its supplemental BLA for Imfinzi (durvalumab) and a new four-week, fixed-dose regimen...

FDA Clinical Hold on Poseida Prostate Cancer Drug Trial

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FDA places a Poseida prostate cancer drug Phase 1 trial on clinical hold while the company investigates the death of a trial parti...

23andMe Clearance for Metabolism Report on 2 Drugs

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FDA clears a 23andMe 510(k) for a pharmacogenetics report for interpretive drug metabolism information on clopidogrel and citalopr...

FDA Posts Regulatory Science Tools for Devices

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FDA posts a catalog of regulatory science tools to help sponsors assess new medical devices.

EUA Given to Yales Saliva Covid Test

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FDA issues an emergency use authorization to Yale School of Public Health for its SalivaDirect Covid-19 diagnostic test.

Info Collection on Rapid Surveys

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Federal Register notice: FDA sends to OMB an information collection extension for Food and Drug Administration Rapid Response Surv...

Trump Holds Meeting on Another Unproven Covid-19 Therapy

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President Trump turns some attention to an extract from the oleander plant as an unproven cure for Covid-19, leading to speculatio...

ClinicalTrials.com Civil Money Penalties Guide

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Federal Register notice: FDA issues a final guidance on ClinicalTrials.com civil money penalties.