PDA Regulatory Conference 2025: Wrap Up

Hot topics discussed at the Parenteral Drug Association's (PDA’s) 2025 Regulatory Conference included quality culture, complete response letters, import alerts, artificial intelligence, and transparency. In the above video interview, Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates, joins PDA CEO Glenn Wright and Melissa Seymour, executive vice president, Global Quality, Eli Lilly and Company, to talk about the regulatory and quality topics discussed at this year’s conference.

“One of the topics that came up [is that] we kicked off, really the whole week by a session on Sunday, on complete response letters,” Wright said about one of the more popular topics discussed at the event. “That came up repetitively in several of the sessions. So, you know, I think complete response letters is a topic that's going to continue to be important for the industry, and we're going to have to work on. I think I was surprised. We set out a session for 90 minutes. We thought, we’ll probably get 60 minutes, and that'd be about it. It ran 100 minutes, and we basically had to say, hey, we're going to have to stop the discussion, because we're out of time, right? And so that was a really interesting session, and that there is still a huge amount of industry interest on that topic of complete response letters, and that percentage and number of letters that are coming out.”

Click the above video to watch the interview.

Check out all our PDA 2025 coverage!

About the interviewees

Susan J. Schniepp is Distinguished Fellow, Regulatory Compliance Associates, a Nelson Labs company and Chair of the PDA BoD.

Melissa Seymour is Executive Vice President, Global Quality, Eli Lilly and Company and Chair-elect PDA BoD.

Glenn Wright is President and CEO at PDA.