2022-19713: Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; List Under the 21st Century Cures Act
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As required by the 21st Century Cures Act (Cures Act), the Food and Drug Administration (FDA, Agency, or we) is finalizing a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. A combination product is a product composed of any combination of a drug, a device, and/or a biological product.
The agency’s own summary, as published.
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