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CPC Provides Comments on FDA’s Proposed Approach for Sponsors Requesting Agency Feedback for Combination Products

On February 24, 2020, CPC submitted comments on FDA’s draft guidance “Requesting Food and Drug Administration Feedback on Combination Products.” CPC appreciates FDA’s efforts to enhance clarity and transparency of regulatory considerations for combination products through the publication of the Draft Guidance outlining the feedback mechanisms available to sponsors. However, CPC has identified the following overall concerns and suggestions:

•  FDA should revise the Draft Guidance to describe the parameters for CPAM interactions, including when a CPAM would be appropriate over an application-based mechanism along with examples.
•  CPC recommends that FDA include opportunities for iteration of proposals, which are linked back to the earlier discussion to allow for sponsors to receive FDA feedback, revise proposals and discuss with FDA until ‘agreement is reached,’ which is common to other types of formal meetings.
•  CPC recommends that FDA provide more detailed timelines for the CPAM submissions and responses.
•  The guidance should focus on the new or distinct information related to combination product meetings through the application-based and CPAM mechanisms and remove the content that is duplicated from other guidance.