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U.S. New Drug Application & FDA Approvals

Overview

What Is FDA Approval?
FDA approval indicates that CDER (Center for Drug Evaluation and Research), or CBER for biologics, has reviewed the drug’s preclinical and clinical trial evidence to determine its efficacy, safety, and the drug’s benefit is determined to outweigh its potential risks in the target population. The FDA does not test or develop drugs, they review the results of studies done by the drug manufacturer.

FDA Decision
After reviewing the New Drug Application, the FDA will either approve the drug for marketing in the U.S. or issue a Complete Response Letter explaining why the drug was not approved. The response letter is most commonly in response to safety or efficacy issues the FDA identified regarding the drug product. This does not mean the drug is totally denied approval, it simply means the FDA feels that the application is not ready for approval.

It is estimated that 1 in every 5000 drug candidates make it from preclinical testing to approval.

In this module, learners will read about the various drug applications and accelerated approval tracts.

Learning Objectives

  1. Identify components and goals of a New Drug Application
  2. Compare different types of drug applications (NDA, BLA, ANDA)
  3. Provide a summary of the FDA approval process
  4. Briefly describe the various FDA faster approval tracts to bring drugs to market more quickly