This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of drug delivery combination products as defined by US FDA regulation. It will also address other types of drug delivery products where the combination must be considered. Attendees will gain insights into the various categories of these products and the regulatory landscape governing their development and approval.
The session will detail the current technical expectations for the development of drug delivery combination products, highlighting the importance of incorporating Design Verification approaches. This includes an in-depth look at FDA Essential Performance Requirements (EPRs), the recently updated ISO 11608 series, and FDA and IEC requirements for addressing human factors.
Participants will also learn about the Good Manufacturing Practice (GMP) and system requirements mandated under FDA 21 CFR Part 4 regulations. These regulations are critical for ensuring that combination products meet the necessary safety and efficacy standards.
In addition to the regulatory and technical aspects, the presentation will cover the clinical requirements and unique challenges associated with developing generic drug delivery combination products. Attendees will gain a thorough understanding of the specific considerations and hurdles that must be addressed during the development process.
By attending this presentation, professionals involved in the development, testing, and regulatory compliance of drug delivery combination products will acquire valuable knowledge on meeting FDA and international standards. The session will provide practical insights into navigating the complex regulatory environment, ensuring that their products comply with all necessary requirements and perform effectively in clinical settings.