Understanding Regulations

United States Regulations

The Role of the FDA

The US Food and Drug Administration (FDA) is responsible for safeguarding public health by ensuring that current and new medical products are safe and effective, and that the evaluation of potential new therapies is done properly.

It is here to protect and promote your health, and protect your rights as a participant in clinical trials. This includes a series of regulations to monitor clinical trials, which govern elements like:

• What must be communicated to patients

• Consent requirements

• The data collection process

• What information is required for a trial to be started

• Requirements for clinical trial study sites

• How the process will be monitored

• The importance of patient privacy

• Additional protections for children

Pharmaceutical companies that wish to test an investigational drug through a clinical trial must strictly follow these guidelines.

Visit the FDA's website to learn more about its role in the drug development testing and monitoring process.