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Legend Biotech : MASTER TECHNOLOGY TRANSFER, MANUFACTURING AND CLINICAL SUPPLY SERVICES AGREEMENT FOR BCMA CAR-T PRODUCT - Form 6-K

MASTER TECHNOLOGY TRANSFER, MANUFACTURING AND CLINICAL SUPPLY SERVICES AGREEMENT FOR BCMA CAR-T PRODUCT

This Master Technology Transfer, Manufacturing and Clinical Supply. | April 14, 2023 ....

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FDA promotes pre-approval for changes to AI devices via Predetermined Change Control Plans | Hogan Lovells

On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined. ....

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FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped? | King & Spalding

First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical. ....

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FDA Releases Guidance on Submissions for AI/ML-Enabled Devices | Foley Hoag LLP

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations. ....

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Investegate |Trackwise Designs Announcements | Trackwise Designs: Contract and Trading Update

Investegate announcements from Trackwise Designs, Contract and Trading Update ....

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