FDA Signals Flexibility on Alternatives to Animal Testing, Law360 Healthcare Authority

Partner Jacqueline R. Berman was quoted by Law360 Healthcare Authority in an article examining the US Food and Drug Administration’s draft guidance encouraging drug developers to reduce reliance on animal testing and consider alternative methods.

Jacqueline noted that the proposal indicates openness from regulators but emphasized that practical application will evolve over time as industry engagement increases. “The big question is what NAMs FDA will accept and what they will substitute for,” Jacqueline said. “And I think that we'll only really see as industry begins to use these, begins to talk with FDA about these, and products that have relied on these work their way through the pipeline.”

Read the full Law360 Healthcare Authority article >>