FDA’s Drug Review Process in 12 Simplified Steps

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FDA’s Drug Review Process in 12 Simplified Steps

FDA drug review steps simplified

1) Preclinical (animal) testing.

2) An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.

3) Phase 1 studies (typically involve 20 to 80 people).

4) Phase 2 studies (typically involve a few dozen to about 300 people).

5) Phase 3 studies (typically involve several hundred to about 3,000 people).

6) The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.

7) Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.

8) After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.

9) If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness.

10) The FDA reviews information that goes on a drug’s professional labeling (information on how to use the drug).

11) The FDA inspects the facilities where the drug will be manufactured as part of the approval process.

12) FDA reviewers will approve the application or issue a complete response letter.

This article was originally published on the FDA website. To download the available infographic and read the full article, visit the FDA website at


The FDA’s Center for Drug Evaluation and Research provides this great downloadable PDF infographic on the Drug Approval Process. Download it here.

Want to learn more about the drug approval process?

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