The Road Ahead For Drug Development In The US, Law360

Partner Jacqueline R. Berman and of counsel Ariel Z. Seeley co-authored an article for Law360 analyzing the US Food and Drug Administration’s draft guidance on the use of new approach methodologies (NAMs) in drug development and its broader implications for innovation and regulatory strategy.

The authors examine how the guidance reflects increased FDA openness to alternative, technology-driven testing methods, while introducing a flexible but evolving validation framework centered on context of use, human relevance, technical characterization, and fitness for purpose. They highlight ongoing ambiguity around validation requirements, the more limited applicability of NAMs in medical device development, and the agency’s broader push to reduce development costs and timelines. The article also outlines emerging opportunities for technology companies, alongside the need to navigate complex regulatory, clinical, and data integrity requirements.

Read the full Law360 article >>