The regulation of investigational drugs

Article Abstract:

The process by which the U.S. Food and Drug Administration (FDA) regulates the development and availability of new therapeutic agents is examined. The FDA process for regulating investigational drugs includes the following broad stages: submission of an Investigational New Drug application (IND) as the first step in the clinical investigation process; review of IND by an institutional review board which examines the scientific validity of a study to insure that subjects are not exposed to unnecessary risk; monitoring of patient safety as a continuing means of assessing the risks posed by the study; use of the drug by some patients who are called 'treatment INDs', patients with life- threatening diseases who are not enrolled in the clinical trial but may benefit from drugs that are in advanced stages of the testing process; a 'compassionate use' stage, which covers some instances in which a physician may need to use an investigational drug for which no IND is yet in effect; and unapproved use of an approved drug, allowed by the FDA if no substantial risk is involved and if the sponsor does not intend to present data to the FDA in support of new uses or changes in the drug's approved labeling or promotional materials. The FDA must balance the goals of accelerating the availability of new drugs with the need to provide greater assurance of the safety and effectiveness of these drugs. Items which must be considered are the necessary level of FDA involvement in the early stages of testing, the appropriateness of the standards of safety and effectiveness set, and what should be considered as meeting those standards.

Evaluation, Clinical trials, Zidovudine, Therapeutics, Experimental, Therapeutics research

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The regulation of discovery and drug development

Article Abstract:

The U.S. Food and Drug Administration (FDA) regulates commercial drug development while providing an opportunity for scientific discovery through clinical research. The process of initiating the clinical investigation of new drugs is crucial for influencing the innovation of new therapeutic agents. FDA regulations governing clinical research involving new drugs were revised in 1987, in order to limit the FDA's involvement to issues of safety during the early stages of the administration of new compounds to humans. The new regulations were intended to reduce the inhibiting effect of the federal bureaucracy on the process of scientific discovery and new drug development. Research which focuses on both compounds that are drug candidates and those employed as investigational tools produces knowledge of both, while studies of new compounds yields knowledge of both drug action and human pathophysiology. The FDA should maintain an openness to the incorporation of new techniques, but the use of randomized trials should not be abandoned.

Human experimentation in medicine, Human medical experimentation, editorial

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The federal regulation of food labeling: promoting foods to prevent disease

Article Abstract:

The laws which govern the labeling of food with respect to identifying the product contents, nutritional content and ingredients used need to be reexamined. Food standards should encourage the development of new products that could contribute to a healthy diet while restrictions on making health claims will ensure manufacturers will make every effort to meet the standards in order to be able to make the claim. Labels on food should convey specific, valuable, accurate information about a product's nutritional value. Credibility of food labels can be maintained by stricter regulations of both the type and amount of information required on labels and the types of health claims allowed.

Interpretation and construction, Food law, column

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