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CGMP Violations at TJA Health

[ Price : $8.95]

FDA warns Joliet, IL-based TJA Health about CGMP violations in its manufacturing of finished drugs.

Quality CDMO Marketing Unapproved Drugs: FDA

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FDA warns Fort Worth, TX-based Quality CDMO that it is marketing five unapproved new drugs.

Consider Phased DSCSA Enforcement: PhRMA

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PhRMA asks FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act because many drug company trading par...

Kisqali Expanded Approval for Early Breast Cancer

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FDA approves an expanded use for Novartis Kisqali (ribociclib) combination use with an aromatase inhibitor for the adjuvant treat...

FDA Lifts Partial Clinical Hold on Alzheimers Drug

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FDA lifts a partial clinical hold against Vigil Neuroscience and its ongoing Phase 1 clinical trial of VG-3927, a small molecule t...

CGMP Violations at Italian Drug Plan

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In an untitled letter, FDA says Milan, Italy-based Industria Farmaceutica is manufacturing drugs with CGMP violations.

Positive Data Reported on Lung Cancer Therapy

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Merck and Daiichi Sankyo say their HERTHENA-Lung02 Phase 3 trial evaluating patritumab deruxtecan in certain patients with locally...

Advisory Panel to Weigh AI-Enabled Devices

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Federal Register notice: FDA announces an 11/20-21 Digital Health Advisory Committee meeting to discuss generative artificial inte...

Oncology Drug Multiregional Clinical Trial Guide

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Federal Register notice: FDA makes available a draft guidance entitled Considerations for Generating Clinical Evidence From Oncolo...

Transplant Viral Nucleic Acid Tests in Class 2

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Federal Register notice: FDA classifies quantitative viral nucleic acid tests for transplant patient management into Class 2 (spec...