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FDA drug classification system.

M D Sanborn¹, H N Godwin, J D Pessetto

¹Department of Pharmacy, University of Kansas Medical Center, Kansas City 66103.

American Journal of Hospital Pharmacy

|December 1, 1991

Summary

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The U.S. Food and Drug Administration (FDA) classification system prioritizes new drug applications based on therapeutic potential. While efficient for initial review, its ratings may not reflect a drug

Area of Science:

Pharmaceutical Sciences
Drug Regulatory Affairs

Background:

The U.S. Food and Drug Administration (FDA) utilizes a classification system for new drug products.
This system is crucial for managing the review process of Investigational New Drug applications (INDs) and New Drug Applications (NDAs).

Purpose of the Study:

To describe the purpose and application of the FDA's drug product classification system.
To explain how chemical type and therapeutic potential influence drug review priority.

Main Methods:

Expert reviewers at the FDA's Center for Drug Evaluation and Research classify drug products.
Classification is based on chemical type and therapeutic potential to establish review priority.

Main Results:

Drugs with high therapeutic ratings (e.g., 1AA, 1A) receive expedited review compared to those with lower ratings (e.g., 1B, 1C).

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The FDA system is the sole national therapeutic rating system, influencing legislation, clinical evaluation, and formulary decisions.

Conclusions:

The FDA classification system effectively prioritizes new drug products for timely review.
Caution is advised when using the assigned therapeutic rating for purposes beyond initial drug approval, as it may not reflect long-term therapeutic importance.