PDA Letter Article

IG Meetings to Address Complexity of New Products

by Lee Leichter, P/L Biomedical

The unique requirements and challenges related to the development, evaluation, registration, and management of prefilled syringes and combination products have increased in complexity over the last few years and, based on the number of guidance documents from regulatory bodies issued in the last year alone, will only continue to evolve.

For example, in January, the US FDA released its final guidance covering cGMPs for combination products. Weeks later, EMA released its own concept paper on combination products.

To address questions about these regulatory documents and other concerns relating to prefilled syringes and combination products, PDA has organized two back-to-back interest group meetings. The Prefilled Syringe Interest Group will convene May 10, followed by the Combination Products Interest Group on May 11. Experts from industry and the FDA will be on hand both days to outline relevant issues and lead current and prospective interest group members in interactive sessions to clarify requirements and identify potential approaches and solutions.

Current plans are to identify no more than four main topics for discussion within each interest group (two for morning discussions and two for afternoon discussions). There will be a short overview of each topic and, then, experts will facilitate discussions and develop possible approaches or solutions to the topics in question.

Some topics have been tentatively identified; however, in the spirit of interest group collaboration, the interest group leaders would love to hear your thoughts on these, or other topics that would be of interest. Once you register for either meeting, please send your discussion topic suggestions to PDA’s Jason Brown. Any topics not selected for discussion may be used for future interest group meetings.

Learn more about the 2017 PDA Prefilled Syringe Interest Group Meeting and 2017 PDA Combination Products Interest Group Meeting and subsequent PDA Education course.