Pharma & drug development · Reference
What is the FDA drug approval process?
The FDA approval process is the staged pathway a new medicine follows from laboratory research to market authorisation. It runs from preclinical testing through an IND, the clinical-trial phases, and an NDA or BLA submission that the FDA reviews.
From preclinical work to the IND
Before any human is exposed to a candidate medicine, it undergoes preclinical evaluation — laboratory and animal studies that characterise its biological activity and assess safety through toxicology testing. If the results support testing in people, the sponsor submits an Investigational New Drug (IND) application to the FDA. The IND presents the preclinical data, the manufacturing information and the proposed clinical-trial plan. Only once the IND is in effect may first-in-human studies begin, all conducted under Good Clinical Practice.
The clinical-trial phases
Clinical testing is organised into phases that answer progressively broader questions. Phase 1 studies, in a small group, focus on safety and how the body handles the drug. Phase 2 studies look at whether it works for the intended use and refine the approach in a larger group. Phase 3 studies are large comparative trials — often randomised against a placebo or standard care — that confirm effectiveness and characterise safety at scale. Each phase gates the next, so larger, longer studies proceed only when earlier evidence is encouraging.
NDA / BLA review and approval
When the trials are complete, the sponsor compiles the full evidence into a New Drug Application (NDA) for a conventional drug, or a Biologics License Application (BLA) for a biologic. The FDA reviews the package — efficacy, safety, statistics, labelling and manufacturing quality under Good Manufacturing Practice — and weighs whether the benefits outweigh the risks for the proposed use.
A decision may be an approval, a request for more information, or a refusal. Approval is not the end of scrutiny: post-market surveillance through pharmacovigilance continues to monitor safety in real-world use, and can prompt label changes or recalls.
Key facts
At a glance
- Pathway: Preclinical → IND → Phase 1/2/3 → NDA/BLA → approval
- IND: Investigational New Drug application before trials
- Phase 1: Safety and how the body handles the drug
- Phase 3: Large comparative confirmatory trials
- NDA / BLA: Drug vs biologic marketing applications
- After approval: Post-market surveillance continues
Common questions
FAQ
What are the steps in the FDA approval process?+
The main steps are preclinical testing, an Investigational New Drug (IND) application, Phase 1, 2 and 3 clinical trials, and finally a New Drug Application or Biologics License Application that the FDA reviews before deciding on approval. This describes the regulatory pathway, not how any individual medicine should be used.
What is the difference between an NDA and a BLA?+
An NDA (New Drug Application) is the marketing application for a conventional small-molecule drug, while a BLA (Biologics License Application) is the equivalent for a biological product such as a vaccine or a monoclonal antibody. Both are reviewed by the FDA before approval.
What happens after a drug is approved?+
Approval allows marketing for the authorised use, but the FDA continues to monitor safety through pharmacovigilance, may require further studies, and can update labelling or order recalls if new risks emerge.
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