Learning Tracks

This session will explore how CDER makes pre-approval inspection (PAI) and remote regulatory assessment (RRA) decisions – and what industry can do to best position itself for those decisions. Panelist will discuss risk-based approaches to inspection and assessment planning, how facility-level quality and compliance history factors into CDER’s decision-making, and what constitutes meaningful inspection readiness from the Agency’s perspective. Topics will also include clearer criteria for when pre-approval inspections may be waived or deferred, the expanded use of remote or hybrid assessment tools, and practical steps industry can take to support timely communication with CDER. The discussion will focus on fostering a shared understanding of expectations – between the Agency and applicants – to reduce approval delays while maintaining robust oversight of manufacturing quality.

Brian Folian, JD, MS
Deputy Office Director, IO, OSIS, OTS, CDER, FDA

Yiwei Li, PhD
Supervisory Pharmaceutical Scientist, OPMA, OPQ, CDER, FDA

Piyush Modi
Director, Regulatory Affairs, Amneal Pharmaceuticals

Bhupesh Singh Bisht, MPharm
Director, Regulatory Strategies and Labeling, Apotex Corp.