In Law360, Life Sciences Attorneys Examine FDA Draft Guidance on FDA Plausible Mechanism Framework for Individualized Therapies

In a Law360 article, life sciences regulatory & compliance partner Joshua Oyster, counsel Beth Weinman and associates Austin Laroche and Jessica Bushman analyzed U.S. Food and Drug Administration (FDA) draft guidance that details a new regulatory approach — the plausible mechanism framework — for the development of individualized therapies.

The article examines key takeaways from the draft guidance, and identifies significant questions that remain for biopharmaceutical companies and investors interested in the development of personalized therapies.

The authors note that while the draft guidance reflects yet another expression of the FDA's focus on accelerating rare-disease drug development, the numerous important — yet unresolved — questions make it difficult to predict how plausible the new framework will prove to be in practice.