The primary mode of action refers to the most significant therapeutic action of a combination product. This term is defined by the Food and Drug Administration (FDA) as the single mode of action that provides the greatest contribution to the overall intended therapeutic effects. In simpler terms, it identifies the key way in which a product works to achieve its intended health benefits.
The term "primary mode of action" is primarily used in the context of regulatory frameworks governing combination products, which can include drugs, devices, and biologics. It is relevant in areas such as:
Understanding the primary mode of action is essential for compliance with FDA regulations, and users may find it helpful to utilize legal templates and forms from US Legal Forms to navigate the approval processes for these products.
Here are a couple of examples of abatement:
Here are a couple of examples to illustrate the concept:
| Term | Definition | Difference |
|---|---|---|
| Mode of Action | The way a product produces its effects. | Primary mode of action is the most significant among multiple modes. |
| Combination Product | A product made of two or more regulated components. | Focuses on the specific therapeutic action rather than the product itself. |
If you are involved in the development or regulation of a combination product, it is crucial to clearly identify and document the primary mode of action. Consider using legal templates from US Legal Forms to assist in the preparation of necessary documentation. If the process seems complex, consulting with a legal professional may be beneficial.
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A combination product is a product that combines a drug, device, or biologic to achieve a therapeutic effect.