Zdrowie i gospodarka · 13.09.2022
Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; List Under the 21st Century Cures Act
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.