What is the life cycle of drug safety monitoring?

Advertisement
Advertisement
Drug safety monitoring is an ongoing process that begins long before a product enters the marketplace and continues long after it has been made available to patients.

In pre-clinical trials, laboratory experiments determine if a compound is a potential medicine. These are followed by clinical trials, a series of studies (phases I, II, and III) to determine if the drug is safe and effective in patients. Once a drug application is received by the FDA, the FDA examines the safety and efficacy data and may request additional studies. If the drug is approved the medicine is made available to patients. At that point, long-term safety monitoring begins in what are known as phase IIIB and phase IV studies.

Continue Learning about Drug Safety

Drug Safety

Drug Safety

Prescription and OTC drugs marketed in the United States go through a review and testing process by the Food and Drug Administration (FDA). Dosage, side effects, manufacturing and safety are evaluated through this process. Familia...

rize yourself with drug warnings, drug label changes and any drug shortages, so you can protect and maintain your health.
More

Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.