Combination Products: New Guidance Details Process for Requesting Feedback From FDA

Regulatory NewsRegulatory News | 06 January 2020 |  By 

The US Food and Drug Administration (FDA) last month issued draft guidance on requesting feedback from the agency on scientific and regulatory questions during the development of a combination product.
The 18-page draft guidance fulfills an obligation under the 21st Century Cures Act to publish guidance on best practices when seeking feedback on combination products and to explain how combination product agreement meetings (CPAMs) work.
CPAMs are meant to provide combination product sponsors with “clarity and certainty” about a product when the lead review center is clear. FDA is required to meet with sponsors requesting a CPAM within 75 calendar days of receiving the request and document any agreements concerning the product in writing.
FDA is generally expected to adhere to agreements made during a CPAM, though the agency may void an agreement if the sponsor agrees in writing or if newly identified issues or scientific evidence emerge that give the agency cause to deviate from the agreement.
According to the guidance, application-based mechanisms such as the pre-submission process or formal meeting requests are “generally the most efficient and effective approach” for obtaining feedback on combination product development.
In addition to those application-based mechanisms, combination product sponsors may request feedback from FDA through CPAMs, which FDA says, “may complement, but should not replace, application-based mechanisms and should not be used to resolve disputes regarding scientific or regulatory matters.”
FDA says that CPAMs should be reserved for situations where sponsors have already “identified the indication for use and design of the combination product they will pursue and sufficient information can be provided to ensure an effective review.”
The guidance also details the submission process and what information should be included in CPAM requests and outlines how the agency will respond to such requests.


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