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KVK-Tech Recalls 1 Betaxolol Lot

[ Price : $8.95]

KVK-Tech recalls one lot of betaxolol tablets as a precautionary measure after a single oxycodone HCl tablet was found on the pack...

Oncology Panel to Discuss Accelerated Approvals

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Federal Register notice: FDA announces an 11/16 Oncologic Drugs Advisory Committee meeting to hear an update on the agencys accele...

More Unannounced Inspections in India: Califf

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In a wide-ranging TV interview during a visit to India, FDA commissioner Robert Califf says the agency will be increasing both ann...

FDA Reviewers Question Amgens Lumakras Study

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FDA medical reviewers ask the Oncologic Drugs Advisory Committee whether the CodeBreak 200 post-marketing trial of Amgens Lumakras...

AdvaMedDx Challenges Oncology Test Pilot

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AdvaMedDx says it has many questions about an immediately effective FDA guidance on a pilot of oncologic drugs that use in vitro t...

Hospira Recall Over Glass Particulates

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Pfizers Hospira drug unit recalls several drug lots of 4.2% sodium bicarbonate injection, 1% lidocaine HCl injection, and 2% lidoc...

FDA Allows Reformulated Novavax Vaccine

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FDA amends the emergency use authorization of Novavaxs Covid-19 vaccine adjuvanted, for use in individuals 12 years of age and old...

Galderma Sent Complete Response Letter

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FDA sends Galderma a complete response letter on its BLA for relabotulinumtoxinA (QM-1114), indicated for treating frown lines and...

Guide on 510(k) eSubmission Template

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FDA releases a final guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions.

Inspection Derails Lilly Eczema BLA

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FDA sends Eli Lilly a complete response letter due to inspection problems impacting its BLA for lebrikizumab, indicated for treati...