FDA official discusses best practice for requesting feedback for combination products

A US Food and Drug Administration (FDA) official offered advice to sponsors on best practices for requesting feedback for combination products and for submitting requests for designation (RFD) or pre-RFDs for such products at the agency’s Regulatory Education for Industry Annual Conference on 29 May.

Kristina Lauritsen, combination product regulatory advisor and product jurisiction officer for FDA’s Center for Drug Evaluation and Research (CDER), said the key consideration for determining whether a product will be regulated as a drug, device, or biologic is based on the product’s primary mode of action. For example, if the product’s primary mode of action is delivered via a drug, the product is assigned to CDER as the lead review office.

Lauritsen said that a pre-RFD or an RFD should only be submitted if there is uncertainty about the product’s classification, adding that a pre-RFD or an RFD is not needed for most products. “Don’t come in [with an RFD] if the product is a prefilled syringe, you are going to the drug center,” she said.

A pre-RFD is a non-binding decision and is helpful during early development and is a more interactive process than the RFD. Sponsors usually hear from FDA on these requests within 60 days.

An RFD is a binding document that should only be used for well-characterized and configured products, and there is a 15-page limit on these requests. Sponsors usually do not interact with FDA, and similar to the pre-RFD, a decision is made within 60 days of the request.

If sponsors want to meet with FDA, they should direct all meeting requests to the lead center, even if their questions do not involve the lead center. Lauritsen said the lead center should serve as the sponsor’s primary point of contact; the lead center is also able to leverage expertise with other centers on the product if this is necessary.

If the lead center is the Center for Devices and Radiological Health (CDRH), sponsors should submit meeting requests to the Q-Submission program as per the CDRH’s final guidance issued in June 2023.

If the lead center is CDER, sponsors should follow the procedures set in its draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, issued in September 2023.

She also referred biosimilar and generic drug makers to the agency’s respective guidances on formal meetings between the agency and applicants.

In meeting requests, sponsors should only ask questions related to the product’s stage of development and provide sufficient information for FDA to identify whether a constituent part is being used in other development programs to be able to leverage information from other submissions.

For device constituents that are in drug-led combination product, meeting requests should identify the device’s 510(k) or PMA number if it is already authorized for marketing.

REdI meeting

FDA official discusses best practice for requesting feedback for combination products

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