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Dewei Medical Recalls Sample Kits

[ Price : $8.95]

Dewei Medical Equipment recalls its DNA/RNA Preservation Kits because the products were distributed to U.S. customers without FDA ...

FDA Manuscript in the Works on Trial Diversity Strategy

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FDA commissioner Robert Califf says the agency is preparing a manuscript to outline a strategy for getting more diversity into cli...

Moderna, Pfizer Bivalent Vaccine EUAs Amended for Young

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FDA amends the emergency use authorizations of the updated (bivalent) Moderna and Pfizer-BioNTech Covid-19 vaccines for use in chi...

Priority Voucher Used on Imjudo Approval

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Federal Register notice: FDA announces that AstraZeneca redeemed a priority review voucher for Imjudo (tremelimumab), which was ap...

Population PK Modeling for Dosing Alternatives Guide

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Federal Register notice: FDA makes available a final guidance on pharmacokinetic-based criteria for supporting alternative dosing ...

FDA Urges Oncopeptides to Withdraw Multiple Myeloma Drug

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FDA asks Oncopeptides to withdraw the accelerated approval of multiple myeloma therapy Pepaxto (melphalan flufenamide) after a con...

FDA Accelerated Approvals Down This Year: AP

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An Associated Press story says FDA has granted fewer accelerated approval NDAs/BLAs after taking new steps to tighten control over...

FDA Denies Homeopathy Petition

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FDA denies an Americans for Homeopathic Choice petition asking that some homeopathic drugs not be considered new drugs and thus no...

Significant HCT/P Deviations at Cryos International

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FDA warns Orlando, FL-based Cryos International about significant deviations from human cell, tissue, and cellular and tissue-base...

Homeopathic Drug Products Enforcement Guide

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FDA also says it expects that many homeopathic drug products will fall outside the categories of drug products that FDA intends to...