The Combination Product Agreement Meeting (CPAM) offers a permanent mechanism for agreement with the Agency, may be similar to a specific evaluation of the protocol with the Centre for Drug Evaluation and Research and Center for Biologics Evaluation and Research (CBER) (Federal Food, Drug, and Cosmetic Act 505[b][b][B]) or a product development protocol with the Center for Devices and Radio Logic Health (CDRH) (Code of Federal Regulations Title 814.19). The project consists of 18 pages. The purpose of the guideline is to outline the different ways in which a sponsor of a combined product can obtain feedback from the FDA on scientific or regulatory issues. This can be done through an authorisation mechanism, the pre-submission procedure used by CDRH and CBER, and formal meetings with CDER and CBER. Comments can also be provided through Product Agreement Meetings (CPAMs). Second, the FDA says sponsors should provide comprehensive justifications and supportive information. The submission/request should contain sufficient information to allow the FDA to review the issue and provide feedback, without requiring significant additional requests for information. In the event of a request for feedback from the FDA on a particular problem, sponsors should provide, if necessary, sufficient information on how the problem relates to the components and the entire product combined. As described by the FDA, a combined product is a product consisting of some combination of a drug, device and/or biological product. Drugs, devices and biologics contained in combined products are referred to as “components” of the combined product. According to the FDA, if a company does not know if its product is a combined product or component of a combined product or which center is the primary responsibility for the product, the FDA can contact the Office of Combination Products (OCP), according to the FDA. If they wish to obtain a binding statement from the FDA regarding the classification and/or allocation of funds, they can apply for designation (DCD) with the OCP or receive informal feedback, they can submit a pre-RFD to the OCP.
The framework confirms both similar exercises, often used in most organizations consistent with good manufacturing practices and 21 CFR 820, and a useful exercise for the uninitiated, listing three hypothetical examples of evaluation and identification of achievable data and defining the remaining gaps in a combined development program that may require transition studies of different types to support the relevance of the proposed data that can be based. Once a combined product is almost fully designed and understood in sufficient detail to allow for a debate on scientific and technical specificities, it may be possible to agree with the FDA`s management center with the CPAM data development plans that, if completed as agreed, will allow for timely enforcement. Choosing the right partner can help you optimize the development path and make the most of your interactions with the agency. Learn more about our services at www.regprofessional.com/services/. The analytical framework described in the Combined Products guide for the transition of drugs and biologics is a process that many of us apply every day in one way or another.