Regulatory Deep Dive

Jun 1, 2022 | Research Report


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  • The FDA has two approval pathways for medical devices and drugs, depending on the product.
  • A combination product is a mix of two or more regulated components that are combined or mixed together as a single entity.
  • The primary mode of action (PMOA) determines which pathway a combination product will be reviewed under.
  • Regranex is an example of a drug that was approved with a Biologics License Application (BLA).
  • Gene therapy is another example of something that falls under the BLA category because it alters genetic composition and needs to be “metabolized” to produce its effect.
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