Combination Products Coalition (CPC)

News

CPC Comments on FDA’s Statement of Work for the Independent Assessment of Communication Through Product Quality Information Requests During Application Review

On November 14, 2022, the CPC submitted a comment letter to FDA in response to the Agency’s request for comments on its statement of work for the independent assessment of communication through product quality information requests during application reviews that will be conducted in PDUFA VII. In its comment, the CPC requests that the assessment, or another similar assessment, include information requests related to drug and/or biologic-led combination products.

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CPC Comments on FDA’s Draft Guidance “Computer Software Assurance for Production and Quality System Software”

On November 14, 2022, the CPC submitted a comment letter to FDA regarding the Agency’s draft guidance, “Computer Software Assurance for Production and Quality System Software”. The CPC greatly appreciates FDA’s efforts to provide this draft guidance, which helps to establish Agency expectations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. The CPC’s comments focus on applicability of the draft guidance to pharmaceutical- and drug-primary mode of action combination product production and quality system software.

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CPC White Paper to FDA Regarding Validating Specifications
On October 17, 2022, the CPC submitted a white paper to FDA detailing CPC’s position with respect to recent requests from FDA to demonstrate how companies have “validated” device user interface specifications in intended user population(s). The document lists specific concerns of CPC member companies and offers case study examples to highlight a range of experiences. As discussed further in the white paper, CPC seeks clarity on the Agency’s expectations for validation of product user interface specifications and confirmation of the context in which such validation expectations are applicable.

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