How New Medicines Are Approved by the US FDA

Constantly developing new medications to treat a variety of health conditions is a necessity in today’s world. We are haunted by the symptoms and effects of diseases that affect us and our family. Taking medications help us get better.

Before patients can get access to the latest medicines for certain health conditions, these medicines will have to go through a series of clinical studies in Florida.

The purpose of a clinical study

A drug manufacturing company cannot just mass produce a new medication. It has to be regulated to ensure its safety on the intended recipients; its benefits outweighing the potential risks of the said medicine. Through clinical research studies in Tampa, Florida, the safety, benefits, and risks of newly developed medications can be identified and evaluated.


The agency responsible for regulating the production and use of a wide variety of drugs for treatment and use among patients in the United States is the US Food and Drug Administration (FDA). A sub-division of the US FDA, the CDER or Center for Drug Evaluation and Research is the specific team who conducts evaluations for new drugs in the market before such drugs are sold publicly.

The CDER team is typically composed of scientists such as physicians, chemists, statisticians, and pharmacologists, among others. They work together to determine how safe and how effective the proposed new treatment drug is.

The process

Typically, when a drug company expresses interest in selling drugs within the United States, they will need to have their products tested beforehand. In most cases, these medicines are tested via laboratory or animal tests first. This will help determine if the drug can be safely administered to humans.

Afterwards, medical studies in Florida will then be conducted, this time with humans as volunteer subjects. Extreme caution, care, and observation are necessary to ensure the safety of the volunteers at all times.

The results of these laboratory tests are then submitted to the CDER. Along with the results, the CDER team will also review the data and product labeling proposed by the drug company. If the team sees the safety and effectiveness of the drug, they will give the FDA approval for the drug’s mass distribution.

Avita Clinical Research conducts tests on human patient volunteers who can help us determine how safe and how effective a newly developed drug is. To know if you can be one of our volunteers, please contact us today!

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