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Everything You Need to Know About the FDA Approval Process


Posted by skymedicus STAFF on 7/27/2017 1:47 PM | Last Modified: September 26, 2017


The United States Food and Drug Administration (FDA) is responsible for assuring consumers that drugs and treatment offered in the US are quality, safe, and effective. The process can take up to ten years, so a drug can be clinically proven to be safe and effective years before the FDA approves the treatment for sale in the US.

The testing process, which is conducted by the drug company that developed the treatment, starts with tests to show that the drugs in the treatment are safe and effective in animals. FDA approval is necessary of these test results for the drug to move to human trials.

The first round of human trials (Phase 1 clinical trial) is done with low doses of the drug on healthy people. This testing will show any possible side-effects that the drug may have. The next trial (Phase 2 clinical trial) is done on a group of people who are not healthy and need the treatment. The group is comprised of a few hundred people, the group is divided into two groups, “study group” and “control group”. The control group receive a placebo, or sugar pill, while the study group is given the real drug. This continues to test the safety of the drug and also to establish efficacy of the drug in treating the disease. Early indications of effectiveness can also be gathered during this trial.

The next trial (Phase 3 clinical trial) involves thousands of participants to test the effectiveness of the treatment. Again, half are given a placebo and half are given the treatment. The goal of this trial is collect additional data on the effectiveness of the treatment. After trial is completed, the drug company submits their data and results to the FDA, which then takes six to ten months to review the trials and decide whether the treatment can be sold in the US.

Other countries have shorter time periods for testing safety and efficacy of a new drug submitted for approval. While the trial period is shorter the results are carefully reviewed relative to safety and effectiveness. So many effective treatments can be found available outside the US before the FDA approves the same treatment in the US. SkyMedicus offers options outside the US for treatments that do not have the FDA's approval, but have been approved by the appropriate agency in a particular country to assure safety and effectiveness. Receiving a treatment that does not have the only kind of safety standard that you are familiar with can be scary, but the FDA approval is an assurance that a treatment follows a protocol that was mandated by the FDA.

To be added to the SkyMedicus system, healthcare providers must be highly qualified and have a proven track record with safe and effective procedures and treatment protocols.

Learn More

To learn more about medical tourism, contact the SkyMedicus team today. Your consultation with us is free, and we never charge a fee of any kind unless and until you choose to book your treatment with us. Our focus is on your well being – not on your wallet!

For more information on medical tourism and factors that you need to consider to have a safe and successful experience, download our FREE eBook:

Download our free eBook on the 10 things to know about Medical Tourism

Topics: Food and Drug Administration (FDA)


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