PDA Capital Area Chapter Roundtable – FDA Complete Response Letters: A Growing Industry Challenge with Big Impacts

In recent years, the industry has seen a sharp rise in FDA Complete Response Letters (CRLs) tied to manufacturing and facility related issues—letters that can delay approvals, disrupt supply chains, and impact patient access. This PDA Capital Area Chapter Roundtable will examine the increased frequency and significance of these CRLs, providing a timely overview of the challenges they present and the implications for regulatory strategy and operational readiness.

Attendees will gain insight into PDA’s ongoing efforts to analyze and understand the underlying issues causing the CRL trends and recommended actions being proposed to reduce the trend. The session will feature perspectives from PDA leadership, legal experts, and regulatory affairs professionals, and will conclude with an interactive discussion on next steps for industry action.

Maximize your learning by registering for the post-roundtable PDA Regulatory Conference 2025! Gain in-depth knowledge and practical insight through focused sessions, interactive discussions, case studies, and timely regulatory updates – all designed to help you apply CGMP principles with confidence and precision. Register today – early rates are available for a limited time!

All roundtable registration fees will be donated to the PDA Jette Christensen Early Career Professional Grant, supporting the next generation of pharma leaders.