chapter  K5
4 Pages

Regulatory Affairs

WithGraham Patrick

Regulatory bodies such as the Food and Drugs Administration (FDA) in the USA are responsible for approving whether a drug can proceed to clinical trials and whether it should be allowed on the market. The FDA is responsible for assessing clinical information and approving the start of clinical trials. Dialog then continues between the FDA and the company as the clinical trials are carried out. The Investigational Exemption to a New Drug Application should contain information regarding the chemistry, manufacture and quality control of the drug. In order to get a drug onto the market in America, a pharmaceutical company has to submit a New Drug Application (NDA) to the FDA. The FDA has inspectors who will visit clinical investigators to ensure that their records are consistent with those provided in the NDA, and that patients have been adequately protected.