Zdrowie i gospodarka · 13/06/2018

Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; Proposed List Under the 21st Century Cures Act

The US Food and Drug Administration (FDA) is proposing alternative mechanisms for complying with current Good Manufacturing Practice (CGMP) requirements for combination products, as mandated by the 21st Century Cures Act. Combination products, which include drugs, devices, and biological products, will be subject to these streamlined regulations.