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Does complexity cause confusion for combination products?

Regulatory issues, such as which pathway to choose, and treatment advances, add to the complexity of combination products.

Regulatory issues, such as which pathway to choose, and treatment advances add to the complexity of combination products.
Regulatory issues, such as which pathway to choose, and treatment advances add to the complexity of combination products.

Patches, inhaled insulin, an absorbable sponge, surgical mesh, and a coronary stent system are among the examples of combination products approved by and listed on the U.S. FDA’s Office of Combination Products’ website.

Potential confusion from emerging therapies is addressed head-on by the agency in the following statement:

“Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. FDA expects to receive large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers, which are made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH).

“Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory, policy, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.”

Earlier this year, Drug Development & Delivery ran a story on Human Factors testing alongside clinical trials.

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