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Regulatory Focus™ > News Articles > 2019 > 12 > FDA Drafts Guidance on Bridging Data for Combination Product Applications

FDA Drafts Guidance on Bridging Data for Combination Product Applications

Posted 18 December 2019 | By Michael Mezher 

FDA Drafts Guidance on Bridging Data for Combination Product Applications

The US Food and Drug Administration (FDA) on Wednesday issued draft guidance explaining how drug-device and biologic-device combination product sponsors can bridge data from earlier stages or development or other development programs to support an application.
 
In the 14-page draft guidance, FDA describes how sponsors can develop an analytical framework for identifying information gaps that could be addressed with bridging. The draft provides three examples of bridging scenarios for different drug-device combination products.
 
The draft guidance comes just after the deadline set in FDA’s Prescription Drug User Fee Act (PDUFA VI) goal letter to issue guidance on the topic by the end of FY2019. FDA is also committed to finalizing the guidance by the end of FY2022.
 
Guidance
 
The guidance itself addresses two scenarios where information may be bridged: when the device constituent of the product is different, but the drug or biological product constituent is the same, and when the drug or biological product constituent is different, but the device constituent is the same.
 
FDA defines bridging as "the process of establishing the scientific relevance of information developed in an earlier phase of the development program or another development program to support the combination product for which an application is seeking approval."
 
According to FDA, once a sponsor has bridged information about a combination product, it may be able to "leverage that information to streamline the development program."
 
FDA notes that in some cases sponsors will either need to own the information they are bridging from or have the rights to reference that information in an application.
 
FDA specifies that the guidance only applies to combination products subject to an investigational new drug (IND) application, new drug application (NDA) or biologics license application (BLA) and does not extend to products covered in a final or tentative over-the-counter (OTC) monograph.
 
FDA also explains that the amount of information that can be leveraged depends on the specific combination product, and in some cases bridging may not be possible.
 
“For example, a change in route of administration for a complex biological product may raise additional safety and/or efficacy considerations, and such considerations may make it difficult to bridge to the proposed combination product,” FDA explains.
 
To develop a bridging approach, FDA recommends sponsors conduct a gap analysis following a five-step process that involves identifying differences between two combination products; identifying existing information about the proposed product; determining how information on the first product can be bridged to the second; determining any gaps in that information and whether any other existing information could address those gaps; and finally, identifying any remaining gaps from the previous steps to determine what remains to be addressed in an application.
 
The three examples provided in the guidance follow the stepwise approach and include:
 
  • Bridging within an IND from a drug developed in a prefilled syringe to a drug developed in an autoinjector;
  • Bridging from one autoinjector (prototype 1) to another autoinjector (prototype 2) from the same drug; after Phase 3 studies have been completed but before NDA submission; and
  • Bridging data from a combination product that employs the same device combined with a different drug.
 
FDA

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