PDA Regulatory Conference Features More than 30 FDA Experts

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com

The Parenteral Drug Association (PDA) Regulatory Conference, marking its 34th year, will offer a forum for dialogue between global regulators and industry professionals from the pharmaceutical sector (1). Though FDA is not an official co-sponsor of the 2025 event, more than 30 FDA experts will participate as speakers, moderators, and panelists, underscoring significant agency support. The conference theme, “Achieving Current Good Manufacturing Practice Excellence: Sustainable Compliance Across the Lifecycle,” directly addresses core challenges and objectives for professionals in pharmaceutical manufacturing and development. This sustained engagement from FDA leadership provides crucial opportunities for the industry to deepen its understanding of regulatory expectations and evolving compliance landscapes.

Understanding FDA priorities and compliance trends

A key focus will be the second plenary session on the first day, dedicated to current good manufacturing practice compliance trends and topics (2). This session is particularly relevant for professionals seeking to strengthen their compliance frameworks and advance their quality systems to meet global standards. Speakers will include Francis Godwin, Director, Center for Drug Evaluation and Research (CDER) Office of Manufacturing Quality; Jonathan Swoboda, Consumer Safety Officer, Center for Biologics Evaluation and Research (CBER) Office of Compliance and Biologics Quality; Jeffrey Meng, Associate Director, Emerging Technologies and Advanced Manufacturing, Office of Inspections and Investigations (OII) Medical Products Inspectorate; and Dillard Woody, Branch Chief, Center for Veterinary Medicine (CVM) Office of Surveillance and Compliance. Their presentations will offer detailed insights into the latest compliance trends, which is essential for maintaining regulatory adherence and ensuring patient safety. Following this, FDA officials are scheduled to contribute as speakers and panelists across most breakout sessions, providing further detailed discussions on various topics (2).

Navigating regulatory challenges and enforcement outlook

The third day of the conference will feature “Plenary 4: Regulatory Priorities and Enforcement Outlook,” a session critical for professionals seeking to understand FDA’s focus areas and potential enforcement actions (2). This plenary will feature presentations from Melissa Mendoza, Director, CBER Office of Compliance and Biologics Quality; Jill Furman, Director, CDER Office of Compliance; Cindy Burnsteel, Deputy Director, Drugs and Devices, CVM Office of Surveillance and Compliance; and Ivy Sweeney, Acting Director, Office of Human and Animal Drug Inspectorate, OII. Anticipating these regulatory shifts and enforcement postures is vital for proactive strategic planning and risk management.

Additionally, a preconference roundtable hosted by the PDA’s Capital Area Chapter on Sunday, September 7, focused on FDA Complete Response Letters (CRLs) (2). Thomas Cosgrove, former Acting Director, CDER Office of Compliance, led discussions examining the increasing frequency and significance of CRLs. This session provided a timely overview of the challenges these letters pose and their implications for regulatory strategy and operational readiness in drug development, directly impacting the timelines and resource allocation for new product applications. Registration fees for this roundtable are being directed to the PDA Jette Christensen Early Career Professional Grant, supporting the next generation of leaders in the pharmaceutical sector.

References

1. Parenteral Drug Association. The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda. Press Release. August 28, 2025.
2. Parenteral Drug Association. PDA Regulatory Conference 2025 Agenda. Accessed September 8, 2025.