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Cancer Trial Patient-Reported Outcomes Draft Guidance

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FDA issues a draft guidance with recommendations for sponsor collection of a core set of patient-reported clinical outcomes in can...

8 Information Collections Approved by OMB

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Federal Register notice: FDA announces that eight information collections have recently been approved by OMB.

Neurological Devices Panel Meeting Summary

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FDA releases a summary of the Neurological Devices Panel discussion on the classification of six unclassified, preamendments medic...

Vertex Pharma Gains Expanded Trikafta Approval

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FDA approves a Vertex Pharmaceuticals supplemental NDA for Trikafta (elexacaftor/tezacaftor/ivacaftor) to include certain children...

Steps to Strengthen Drug Supply Chain

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FDA and HHS release a report with recommendations for strengthening the nations pharmaceutical supply chain.

2 Guilty of Falsifying Drug Trial Data

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Two Tellus Clinical Research clinical trial staff plead guilty to charges they falsified trial data.

Continue, Enhance Operational Technology Security: FDA

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FDA says two government agencies should enhance their efforts in the area of operational technology cybersecurity.

Pfizers Prevnar 20 Pneumococcal Vaccine Approved

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FDA approves Pfizers Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for preventing invasive disease and pneumonia caused by...

CyMedica Orthos Knee Pain Neuromodulator Cleared

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FDA clears a CyMedica Orthopedics 510(k) for its IntelliHab for managing knee osteoarthritis pain.

Everything Health Selling Illegal Covid Products: FDA

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FDA warns Everything Health that its Web site and social media pages are selling unapproved and misbranded new drugs purporting to...