From REMS to NAMs: Evolving FDA Revolutionary Regulatory Strategies in 2025

The Modernization Act 2.0 authorizes the use of certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the Food and Drug Administration to investigate the safety and effectiveness of a drug.

The bill also removes the requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product. These shifts open new doors — let’s talk about how to adapt and take advantage of them.

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From REMS to NAMs: Evolving FDA Revolutionary Regulatory Strategies in 2025.

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