PDA Letter Article

Drug Delivery Combination Products Go “Viral”

by Lee Leichter, P/L Biomedical

Insulin Pen Prefilled

Twenty-eight years ago, the term “combination products” was coined and defined in the U.S. Federal Food, Drug, and Cosmetic Act. Since then, the U.S. FDA has progressed slowly in the amount of guidance for these products.

Publication of the draft rule on combination product GMPs in 2009 should have served as a wake-up call that drug delivery products were going to be addressed more than in the past. With the publication of the Center for Devices and Radiological Health (CDRH) draft guidance on human factors for medical devices seven years ago, medical device requirements were expected to be implemented for drug delivery products, even if submitted in an NDA or BLA.

Over the past five years, an explosion of new requirements has occurred as has an unprecedented expansion in the scope of products covered. From standalone software to smart packaging new types of products have entered the pharmaceutical market. With these, are new regulations, such as the EU Medical Device Regulations. This intrusion (“infection”) of new products and requirements has made for an increasingly complex market. Hence, the indication that drug delivery combination products have gone “viral.”

Join invited FDA and EU regulators and industry experts from across the drug-delivery device development spectrum at the 2018 PDA Combination Products Workshop following the 2018 PDA Universe of Pre-filled Syringes and Injection Devices conference in discussing matters related to this expansion. Topics include connected health, generic and biosimilar combination products, new technologies, post-marketing requirements and globalization, among others. Sessions will feature two presentations followed by a panel discussion.

Learn more about the 2018 PDA Combination Products Workshop.