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New FDA Guidance Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics

FDA Issues First Untitled Letter Of The Year To HCT/P Manufacturer - Food and Drugs Law

On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas).

FDA New Untitled Letter to HCT/P Manufacturer

Center for Biologics Evaluation and Research CBER at Food and Drug Administration FDA published first untitled letter of the year to Thomas Advanced Medical LLC for marketing human cells, tissues, or cellular or tissue-based products HCT/Ps without FDA premarket review.

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