FDA regulation of prescription of controlled substances

The Federal Food, Drug, and Cosmetic Act requires the premarket approval of new drugs prior to their marketing. FDA accomplishes this through regulations that establish Investigational New Drug Applications (INDs) and New Drug Application (NDAs). FDA IND regulations address phases of clinical investigations, from Phase I trials involving few subjects, to Phase III trials with thousands of subjects. Under these regulations FDA will not allow an investigation to proceed if human subjects would be exposed to unreasonable risks, investigators are not qualified, or if the investigation protocol is deficient. FDA also requires adequate animal toxicology studies to show it is reasonably safe to administer the drug to human subjects. FDA drug approval regulations protect the public by ensuring that adequate scientific studies have been performed to provide a rational basis on which to conclude that the benefits of a drug outweigh its risks and by assuring that the product is accompanied by sufficient information to permit its accurate prescription. FDA regulations require that the marketing application (NDA) include adequate tests to show whether or not the drug is safe for use under the conditions prescribed, recommended or suggested in the labeling. In addition, there must be substantial evidence, consisting of adequate and well-controlled clinical investigations, that the drug product will have the effect it purports or is represented to have under the conditions prescribed, recommended or suggested in the labeling. Importantly, manufacturing methods and controls must be adequate to assure the identity, strength, quality purity, stability, or bioavailability of the drug product. FDA regulations set forth the "essentials of adequate and well-controlled clinical investigation," including requirements that the study design permits a valid comparison with a control (including, placebo, dose comparison, no treatment, active, and historical) to provide a quatitative assessment of drug effect.