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What is the drug review?

The FDA reviews information that goes on a drugs professional labeling (information on how to use the drug). The FDA inspects the facilities where the drug will be manufactured as part of the approval process. FDA reviewers will approve the application or issue a complete response letter.

What is a formulary review?

A formulary is a continually up- dated list of available medications and related information, representing the clinical judgment, resulting from a review of the clinical evidence, of physicians, pharmacists, and other clinicians in the diagnosis, prophylaxis, or treatment of disease and promotion of health.

Why is understanding drug classification important?

Drug classifications are important. They help protect you from severe side effects and drug interactions. They help ensure your body can break down and use the medication. They help guide many treatment decisions.

What does class mean in drugs?

A drug class is a set of medications and other compounds that have a similar chemical structures, the same mechanism of action (i.e. binding to the same biological target), a related mode of action, and/or are used to treat the same disease.