Food and Drug Administration regulations and licensure

The regulatory requirements of the Food and Drug Administration for products that are defined as drugs and/or biologics are extensively documented in the applicable sections of the Code of Federal Regulations. They include broad requirements for good manufacturing practices and a number of general requirements for matters such as sterility, stability, pyrogens, and labeling. In addition, for biological products, specific standards are published for comment in the Federal Register and then as final rules prior to the acceptance of license applications for new products. The major criteria for such products are safety and effectiveness when the products are used prudently as directed in accompanying circulars. It is generally sound practice to obtain extensive toxicologic and pharmacologic knowledge of potential new products prior to embarking on clinical trials. These trials must be described in investigational new drug applications (INDs), if the products will be entered into interstate commerce. Clinical trials should be planned and conducted using sound scientific and ethical principles in order to obtain objective evidence of clinical effectiveness without unduly jeopardizing the participants in such studies.