The FDA approves a new drug after reviewing evidence that it works for its proposed use and that its expected benefits outweigh its known risks. The agency also evaluates the drug's labeling, manufacturing process and quality controls before allowing U.S.
marketing. Approval follows laboratory research, an application to begin human testing, three typical phases of clinical trials and a final marketing application. The process can stop or require more work when evidence, safety or manufacturing problems remain.
Official resources:
- Apply through FDA’s official page — Use this page to review requirements and apply directly.
- Read the official notice from FDA — Use this primary source to verify the official announcement.
Table of Contents
- What happens before human testing?
- How do the clinical trial phases differ?
- What is submitted for marketing approval?
- What does the FDA review?
- How does accelerated approval work?
What happens before human testing?
A sponsor begins with laboratory and animal studies to examine basic safety, according to the FDA's drug development guide. These studies help determine whether the candidate is ready for testing in people. The sponsor then submits an Investigational new Drug application, commonly called an IND.
It includes animal and toxicity findings, manufacturing information, proposed study protocols, investigator details and any available human data. The FDA generally reviews an initial IND for 30 days. A trial may begin after FDA authorization or after that period if the agency has not imposed a clinical hold, according to the FDA's IND overview.
How do the clinical trial phases differ?
Clinical development typically advances through three phases. Each answers a different question: This sequence does not prove that a drug has no risks. It builds the evidence the FDA later uses to judge whether the drug's benefits outweigh its known harms for the proposed use.
- Phase 1 studies focus on safety and dosage, usually in smaller groups.
- Phase 2 studies examine effectiveness and side effects.
- Phase 3 studies are larger and aim to demonstrate benefit while identifying more adverse reactions.
What is submitted for marketing approval?
To seek permission to market the drug in the united States, the sponsor files a New Drug Application, or NDA. The application contains nonclinical and clinical evidence, analyses, information about the drug and descriptions of how it will be manufactured.
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The FDA has 60 days after receiving an NDA to decide whether to file it for substantive review. Filing means the application is sufficiently complete to review; it is not approval.
What does the FDA review?
A multidisciplinary FDA team evaluates whether the drug is safe and effective for its proposed use and whether its benefits outweigh known risks. Reviewers also assess whether the labeling is appropriate and whether manufacturing controls protect the drug's identity, strength, quality and purity, as described in the FDA's development and review definitions. The review can include inspections of manufacturing facilities.
The agency may also inspect clinical trial sites when needed. If unresolved evidence, safety or manufacturing issues prevent approval, the FDA can send a complete response letter. Approval therefore means the benefit-risk balance supports the proposed use—not that the drug is risk-free.
How does accelerated approval work?
Accelerated approval offers a different route for certain drugs targeting serious or life-threatening illnesses without satisfactory treatments. The FDA may base approval on a surrogate endpoint, a measure used in place of direct proof of a clinical benefit.
The agency may require confirmatory studies after the drug reaches the market. If those studies do not confirm the expected benefit, the FDA can withdraw approval, according to its drug review process explanation.
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