Construction

FINCEN BOIR Filing Dates Reinstated

FinCEN has extended the now (again) mandatory BOIR filing deadline by 30 calendar days to March 21, 2025. The only exception to the mandatory filing requirement are the Plaintiffs in the National Small Business United v. Yellen, No. 5:22-cv-01448 (N.D. Ala) action.

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Artificial Intelligence for Drug & Biological Products – Credibility of AI Models for Context of Use – The “Model Risk” Paradigm

The FDA has recently issued draft guidance (non-binding recommendations) for drug and biological product sponsors and computer programmers regarding the use of Machine Learning (ML) and artificial intelligence (AI) to support regulatory decision-making about the safety, effectiveness, or quality of drugs.

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