What Does the Regulatory Landscape Look Like From the Other Side of FDA?

Harpreet Singh, MD, chief medical officer at Precision for Medicine and former FDA Oncology Division Director, draws on nearly a decade of experience inside the agency to describe how the oncology regulatory landscape looks now that he is advising industry sponsors.

In a conversation with Pharmaceutical Executive, Singh explains that, from her current vantage point, navigating the regulatory landscape is “much more facile” for someone who has worked inside the FDA. She underscores three core principles: engaging with the agency early and often, closely tracking regulatory precedent, and understanding the nuances of each individual division and its decision makers. She stresses that the FDA is “a huge institution” that is “data driven,” but “not a monolith.”

Reflecting on how biopharma perceives the FDA, Singh notes she has been somewhat surprised by sponsors’ assumptions about how decisions are made, and is not sure that it is fully appreciated in industry just how rigorously data driven FDA decision-making is. At the same time, she has also been struck by the “very high regard” in which FDA oncology is held by many of his clients. Singh points out that a number of initiatives launched during her tenure, while they may have introduced additional complexity, extended development timelines, or created short-term confusion, are now generally viewed favorably. Over time, she believes stakeholders have come to see these efforts as part of a constructive, evidence-based approach to advancing oncology drug development, contributing to a broadly positive perception of the agency’s work in this space.