Ever wondered how the medications you rely on make it to the pharmacy shelves? It's a journey that's both rigorous and lengthy, meticulously overseen by the U.S. Food and Drug Administration (FDA) to ensure every drug is both safe and effective for public use.

The process often begins long before a drug even reaches human trials. Many potential medications never make it past preclinical testing in animals. But for those that show promise, the journey truly begins with an Investigational New Drug (IND) application. This is where sponsors present their preclinical findings and propose human testing. The FDA reviews this data to ensure it's safe to proceed.

Next come the clinical trials, a multi-phase process overseen by the FDA and local Institutional Review Boards (IRBs):

  • Phase 1 focuses on safety, typically involving a small group of healthy volunteers to study the drug's metabolism and side effects.

  • Phase 2 expands to a larger group of patients with the target condition to assess the drug's effectiveness and continue monitoring safety.

  • Phase 3 involves hundreds to thousands of patients, gathering more comprehensive data on safety, effectiveness, different dosages, and potential interactions with other medications.

If a drug successfully navigates these phases, a New Drug Application (NDA) is submitted. This extensive document compiles all the animal and human data, analyses, and manufacturing information. The FDA's Center for Drug Evaluation and Research (CDER) then undertakes a thorough review, aiming to act on most standard NDAs within 10 months and priority drugs even faster, often within six months, thanks to the Prescription Drug User Fee Act (PDUFA).

Even after approval, the FDA's oversight doesn't end. Postmarket requirement and commitment studies are often conducted to gather additional information on a product's long-term safety, efficacy, or optimal use in real-world settings.

This comprehensive and multi-stage process underscores the FDA's commitment to protecting public health, ensuring that only thoroughly vetted and reliable medications reach consumers.

For more detailed information, you can visit the FDA's Drug Review Process page.

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Author: Brittany Scott Last Updated: August 6, 2025