Combination product, drug, device and biologic

Combination Products: FDA Releases Guidance on CGMP Requirements

By MedTech Intelligence Staff
Combination product, drug, device and biologic

Manufacturers finally have some clarity on which CGMP requirements apply when producing a combination product.

FDA has released the long-awaited final guidance Current Good Manufacturing Practice Requirements for Combination Products. Although the rule doesn’t set forth any new requirements, it explains which CGMP requirements apply when a combination product is being manufactured to create a “transparent and streamlined regulatory framework for firms to use when demonstrating compliance with applicable CGMP requirements,” according to the document.

The guidance also defines combination product, provides an overview of the rule, explains the role of the FDA centers related to any combination product CGMP matters, and gives hypothetical examples to show companies how to comply with the requirements.

Special Problems and Disconnects for Combination Products

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