Laboratory and Clinical Appraisal of New Drugs

A new drug should pass through several phases of investigation before it is declared suitable for distribution in commerce. It should be studied in the laboratory and in the clinic, the details of the study depending on the nature of the ingredients and the intended uses, but all investigations should follow a general plan which will permit a thorough understanding of the usefulness and toxic properties of the drug. In considering new drug applications in the enforcement of the Federal Food, Drug and Cosmetic Act, the Food and Drug Administration is concerned primarily with evidence of safety. The Council on Pharmacy and Chemistry is concerned not only with the evidence of safety but also the evidence adduced to support the claims made for new drugs. Too frequently this evidence is found inadequate and the sponsors of new preparations, if they wish to provide the missing data, may find it necessary