In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible. Unlike fixed-dose combination therapies, combination products consist of at least two constituent parts, each subject to its own statutory and regulatory requirements.
The Food and Drug Administration has indicated that a single application is appropriate for marketing approval of combination products as determined by the product’s primary mode of action (PMOA). Based on the determination of the combination product’s PMOA, combination products are assigned to an FDA center or a lead center that has primary jurisdiction for its premarket review and regulation.
However, by using a streamlined NDA process, developers can reduce the size and/or scope of the nonclinical and/or clinical program for eligible combination products. By leveraging existing information, the 505(b)(2) pathway can reduce the number and size of studies needed for a combination product’s regulatory approval, lowering costs and accelerating time to market.