Three of FDA’s Centers (CDER, CBER, and CDRH) recently published a combined draft guidance for Industry entitled Bridging for Drug-Device and Biologic-Device Combination Products (here). This draft guidance provides the FDA’s current thinking on what manufacturers should consider when they wish to bridge the data from one such combination product to another combination product during product development (IND-phase) or preparing an NDA or BLA.
This concise guidance document addresses both of the common scenarios: when the manufacturer is developing a combination product that includes a previously approved device component and a new drug or biologic product component, as well as when the manufacturer is planning to change the device component of the combination product without changing the drug or biologic product component. In either situation, the FDA has stated that they “would require additional data and information only if the information were needed to address additional questions of safety or effectiveness raised by the proposed use or function of a constituent part in the combination product.” Although this is a reasonable position for the FDA to take, and may sound like a streamlined approach, manufacturers will still need to thoroughly assess the potential impact of the changes in the component parts on the overall performance of the combination product. In addition, manufacturers need to perform an in-depth analysis to identify any gaps in the information needed to support the proposed combination product’s performance, safety, and effectiveness. All identified gaps need to be filled through additional studies or additional data.
FDA acknowledges, “From a scientific perspective, an applicant must bridge its current application to information developed in an earlier phase of the development program or another development program if the applicant wishes to leverage that information in its current application. For certain types of applications, the use of information from another development program may require that the applicant own the information or have a right of reference.” This is a critical factor in streamlining the process. In instances where the applicant does not own the design of the device component, nor do they have the right to reference, studies will be necessary to demonstrate the safety and efficacy. An example is the filling of a commercially available pre-filled syringe which was not designed and developed by the applicant. In these instances, additional data and studies will be required.
Within the guidance document, the FDA provides a five-step process for performing the requisite gap analysis and recommends that manufacturers subsequently meet with the FDA to discuss what new information or studies may be needed to support approval of the proposed combination product.
The FDA has further increased the utility of the draft guidance by providing three example scenarios illustrating the use of the five-step evaluation when: 1) switching from a prefilled syringe to an autoinjector, 2) switching from one autoinjector prototype to another autoinjector prototype, and 3) using a device component from an approved combination product as the device component in a new combination product with a different drug component.
Given how active the combination product market is and the speed with which new device components are being developed, this guidance from the FDA is both timely and necessary.