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How Many FDA Premarket Applications Are Necessary For Your Combination Product?

This week, we are pleased to share an article written by Camargo Pharmaceutical Services’ new Medical Device expert, Dr. Girish Kumar, along with Dr. P.K. Narang, and published by Pharmaceutical Online, Med Device Online, and Bio Process Online.

How Many FDA Premarket Applications Are Necessary For Your Combination Product?

Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).

As different centers have different review practices and timelines, navigating through the FDA’s regulatory process for approval of such products — depending on their intended use — requires a careful regulatory strategy. Without strategic framework, the overall review time leading to approval can be unnecessarily lengthened, consuming valuable time and resources.

Aligning the sponsor’s goals with the development of these products and with the FDA’s processes is critical, especially in understanding how and when to engage each center with the review of the product or each component of the product. Knowledge of current regulations and framework for assessing product risks can facilitate easier and faster approval of these combination products. The purpose of this article is to clarify various submission strategies a sponsor may need to consider when seeking approval for their product.

Combination Product Definitions

In general, a product can be considered a combination product if it includes at least two of the following, as defined under 21 CFR 3.2(e) — a device component, a drug component, and/or a biologic component. The combination of similar components, such as a drug-drug or a device-device, is not classified as a combination product per FDA regulations. Additional details about the classification of combination products can be found in four subparts within 21 CFR 3.2(e).

To read the rest of the article, please click the link to Pharmaceutical Online