FDA Signals Flexibility in Pitch to Reduce Animal Testing

Healthcare & Life Sciences attorney Sara Klock was quoted in a Law360 article on the U.S. Food and Drug Administration's (FDA) proposed guidance encouraging drug developers to reduce animal testing and expand the use of new approach methodologies (NAMs) in clinical trials. The article examined how the draft guidance may shape the future of preclinical drug development and regulatory review. Ms. Klock explained that the agency's evolving approach could create opportunities for more efficient development pathways, provided sponsors can still demonstrate that alternative methods meet scientific and regulatory standards.

"Ultimately that's the goal – that you still have the same efficacy and the same safety, but the way you got from A to Z looks a little bit different," she said.

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