How The FDA Approves Drugs Before They Are Sold

It’s important to know that the FDA doesn’t approve drugs before they are sold. Instead, it approves a drug for sale once a company has demonstrated to the agency that the drug is safe and effective for its intended use.

How does this happen? It starts with an idea for a new drug, then moves through several stages of development before it reaches consumers. FDA experts can help you through the approval process. You can find a reputable expert agency here. The following article will outline these steps in detail.

  1. Discovery And Development

When a team discovers an interesting drug compound, they take it through animal testing, where much more safety information is discovered. If the test results show no significant side effects but some effectiveness against disease, then clinical trials begin for humans instead of animals. The FDA must approve these trials, but the approval does not mean it is ‘safe.’

  1. Preclinical Research

Preclinical research is a term that means testing on animals to see if the drug causes any harmful or toxic effects. The first stage of preclinical study involves animal models, such as mice and rats.

Scientists inject test subjects with drugs to assess side effects, including how well they are absorbed into the bloodstream. If there are no adverse reactions in these animal tests, the drug moves on to clinical trials.

  1. Clinical Research

The clinical research phase is the most expensive and essential step in drug development. It starts with animal testing to determine a safe dose, effects on organ systems, side effects, etc.

This takes place over four phases lasting about two years per phase: Phase I- safety test of new substance given to 20 – 80 healthy volunteers; Phase II – efficacy and safety test of new substance given to 100 – 300 patients who have the disease; Phase III- efficacy and safety dose-response studies in 2000 – 3000 people, usually those with more severe illnesses or conditions; Phase IV – Postmarketing surveillance.

A drug must pass through every phase before it can be marketed. If a study shows a high probability that the drug will be helpful and safe, it can then go into clinical trials.

  1. FDA Review

FDA reviews drugs submitted for review to ensure that the drug is safe and effective, including measures such as testing of dosage form stability, manufacturing controls, clinical trial data supporting efficacy and safety claims.

After a company submits its information on a drug candidate for FDA consideration (or notifies the agency if it decides against submitting), an assigned FDA staff member often initiates an assessment of the drug for safety and efficacy.

  1. FDA Post-Marketing Safety Monitoring

The FDA monitors medications after their release to make sure that problems don’t go unnoticed. This includes reporting side effects, updating safety information, and removing prescription labels when there is a recall or ban on the medication.

The agency also requires pharmaceutical companies to conduct postmarketing studies if they want the approval of new products. These research projects can be as large and expensive as clinical trials but are less formal than those required for preapproval. In some cases, manufacturers must only analyze sales data from pharmacies or hospitals.


The FDA approval process is a rigorous one that ensures drugs are safe and effective before going to market. While it can be expensive, the safety of patients outweighs any costs associated with drug development.


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