Bringing a new medicine to market is one of the longest, most tightly regulated journeys in any industry, often around nine years from laboratory to pharmacy shelf. Understanding the drug approval process and the applications that gate each stage is essential for anyone working in pharmaceutical regulatory affairs.

It starts with an IND

Before a drug can be tested in people, a sponsor must clear preclinical work (laboratory and animal studies) and file an Investigational New Drug (IND) application with the FDA. The IND is what legally allows human testing to begin; it lays out the manufacturing, the preclinical safety data, and the clinical trial plan, and the FDA reviews it before the first volunteer is dosed.

Three phases of clinical trials

Clinical development then moves through three phases, each answering a bigger question:

• Phase 1 tests safety and dosing in a small group of healthy volunteers.
• Phase 2 looks at efficacy and side effects in a larger group of patients with the target condition.
• Phase 3 runs large-scale trials to confirm effectiveness and monitor adverse reactions before approval.

NDA, ANDA, and BLA: choosing the right application

Once the data are in, the marketing application depends on the type of product:

• The New Drug Application (NDA) is the route for novel small-molecule drugs, filed under the Federal Food, Drug, and Cosmetic Act. Its review typically takes one to two years.
• The Abbreviated New Drug Application (ANDA) is for generics, which skip large clinical trials by proving bioequivalence to an already approved reference drug.
• The Biologics License Application (BLA) covers biologics, monoclonal antibodies, vaccines, gene therapies, filed under the Public Health Service Act, with extra purity and immunogenicity requirements.

The scale of modern drug approval

The bar is high and the output is concentrated: in 2024 the FDA approved 50 new drugs, with roughly half first-in-class and more than half aimed at rare diseases. Each of those approvals represents a successful navigation of the IND-to-NDA/BLA pathway, supported by regulatory professionals who keep the science, the documentation, and the timelines aligned.

Build pharmaceutical regulatory expertise

Drug regulation is a distinct discipline from devices, with its own vocabulary and pathways. Aleph University’s Pharmaceutical Product Regulation course works through the IND, NDA, ANDA, and BLA routes and the clinical-trial framework, within a broader catalog of continuing-education courses in medical devices, regulatory affairs, and quality. New to the field? Start with our guide to regulatory affairs careers.

Ready to learn the drug approval process? Request information and a custom quote for yourself or your team.