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AstraZeneca Hold Lifted on Covid Vaccine Trial

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FDA lifts a clinical hold against AstraZeneca and the University of Oxford to resume clinical trials of their coronavirus vaccine,...

Guide on Drug Distributor Enforcement Delay

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Federal Register notice: FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable...

CDRH Seeking Least Info to Declare Standard Conformity

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CDRH officials say they are looking to identify the least amount of information that device companies need to support a declaratio...

Seizure Monitor Gets Breakthrough Status

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FDA grants Neuro Event Labs a breakthrough device designation for its Nelli, a device designed to automate the identification of s...

Health Experts Criticize FDA Covid-19 Vaccine Plan

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Several health experts criticize FDAs recent guidance on minimum requirements for Covid-19 vaccines to obtain an emergency use aut...

Ex-CEO Gets 6 Months in Drug Marketing Case

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The Western Virginia District Court sentences former Indivior CEO Shaun Thaxter to six months in federal prison for his role in ca...

Warning Letter Sent to CBD Marketer Over Covid Claims

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FDA sends For Our Vets (Mesa, AZ) a Warning Letter after reviewing its Web site and social media sites and determined that it offe...

AuroLife Pharma Hit With Warning Letter

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FDA sends New Delhi-based Aurobindo Pharma a Warning Letter citing its U.S subsidiary AuroLife Pharma based on an inspection at it...

FDA Posts Quarterly FAERS Risk Signal Report

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FDA posts the second quarter 2020 list of potential signals of serious risks or new safety information for drugs identified throug...

OTC Drug Time and Extent Info Collection Extension

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Federal Register notice: FDA sends to OMB an information collection extension for Additional Criteria and Procedures for Classifyi...