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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.