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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). ....

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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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FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer | Sheppard Mullin Richter & Hampton LLP

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. ....

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The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps | King & Spalding

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Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P manufacturers without an FDA-approved marketing application may find themselves subject to FDA scrutiny under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and the Public Health Service Act (“PHS Act”). Firms will have to think hard about whether to submit investigational new drug applications (“INDs”) or marketing applications, wind down production, or risk running afoul of applicable laws and regulations governing unapproved biological products. They should also be mindful of how data collected to date can help to inform next steps. ....

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