ABSTRACT
The Federal Food, Drug and Cosmetic Act is enforced by the Food and Drug Administration (FDA) to assure that all regulated products, including food and color additives, animal food additives, human and veterinary drugs, medical devices for human use, biological products and electronic products, are safe and effective for their intended use or uses. The FDA accomplishes this responsibility regarding safety by suggesting the type and extent of testing that is required, by reviewing new product applications to determine whether or not the contemporary scientific standards of safety have been met; and in certain circumstances, by carrying out independent
scientific studies to confirm the results submitted by product sponsors. Further to this end, FDA requires that all nonclinical toxicity studies be conducted under conditions that assure that the resultant final report is suitable for informed regulatory decision making. The agency believes that this requirement can be met if the toxicology laboratory is operating in accord with universally accepted principles of good laboratory practices (GLPs).
