CPC Submits Comments to FDA’s Draft Guidance on Rheumatoid Arthritis: Developing Drug Products for Treatment

The CPC submitted comments to FDA’s Draft Guidance on Rheumatoid Arthritis: Developing Drug Products for Treatment, noting that that the general drug-device combination product guidance should not be included in RA-specific guidance.  Specifically, the comments requested:

• That FDA delete general information on drug-device combination products and issue it in separate guidance and/or clarify how such information is specific to combination products intended for use in RA treatments.
• That FDA require bench testing instead of additional clinical data for a bridging study for all modifications to the combination product not involving a change to the formulation of the drug constituent part or a change to the device constituent part that would result in a new route of administration.
• Clarification on FDA’s requirement for a “real-life use study” when transitioning between a pre-filled syringe to an autoinjector.
• That FDA reconsider its recommendation the human factors studies be conducted early in the development of a RA drug product.