| Pharmacologic Concept Description |
An established pharmacologic class is a term or phrase that is scientifically valid
and clinically meaningful according to the following definitions:
- A scientifically valid pharmacologic class is supported by documented and submitted empiric evidence showing that the drug's pharmacologic class is known, not theoretical, and relevant and specific to the indication.
- A clinically meaningful pharmacologic class term or phrase enhances the ability of professionals to understand physiologic effects related to the indication or to anticipate undesirable effects that may be associated with the drug or pharmacologic class.
|