When was the office of combination products established

Cross-labeled products often fall into this category, as they are the least clearly defined combination product types. The first combination products to fall under FDA regulatory authority were developed in the s and included radio-biologics and in vitro diagnostics. Over the next two decades, combination products were regulated by the Agency on an ad hoc basis, which included the use of inter-agency agreements.

It designated that the FDA have primary jurisdiction. The FDMA addressed pre-market approval, notification, classification, labeling, tracking, surveillance, and establishment registration, to name a few of the areas of focus.

The regulatory strategy for developing such products needs to be well-designed and should factor in both adaptability and the manufacturing process to minimize overall program risk. Having an adaptive regulatory strategy is the key to beneficial interactions with the Agency from the beginning. A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, a device, and a biological product.

Sometimes two separate components are co-packaged like a kit of a syringe, mixing solvent chamber, and drug or even packed and sold separately but meant to be used together to achieve a diagnostic or therapeutic effect like a laser-activated drug for photodynamic therapy.

In all of these scenarios, the key point is that each constituent is required to achieve the desired function for the proposed indication. When considering the regulatory strategy for a combination product program, the first questions that sponsors confront are whether an IND or an IDE will be required, and who will make that decision. The unique cross-industry membership of the CPC enables diverse thinking that leads to sound policies. This diversity distinguishes the CPC from other industry organizations.

To that end, the Coalition focuses on developing and advocating policy positions on issues affecting combination products. With membership in the Coalition come certain rights and privileges. Among them is the right to have a say in all decisions made by, and activities undertaken by, the Coalition. These working groups are reviewed annually to ensure alignment with CPC member company priorities. Description: Comparability studies for combination products, including the bridging of data from combination products that employ different device components for the same drug or biologic and the same device component across different drugs and biologics, is often required as manufacturers bring products through development to commercial market.

Description: As the area of digital health grows, FDA is re-evaluating the appropriate level of oversight and regulation. It is important for industry to stay abreast of current FDA thinking.

The CPC Digital Health Working Group seeks to advocate for consistent and predictable development and submission requirements for investigational and commercial digital health combination products and aims to present a unified industry position on combination product digital health-related topics.

Description: By evaluating industry experiences, case studies and solutions, we seek to align on best practices regarding combination product post-marketing safety related global topics. We also seek to present a unified industry position to health authorities in response to evolving global post-marketing safety rules and guidance for combination products. Description: The expectations for Human Factors work in combination product development has been evolving for many years.

The Human Factors Working Group advocates for appropriately-scoped human factors programs along with well-timed and actionable FDA feedback.

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