Overview of Clinical Trials and Post Marketing

Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever. Postmarketing study commitments are studies required of or agreed to by a sponsor that are conducted after FDA has approved a product for marketing. FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use.