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AMA Department of Drugs
Chicago

JAMA. 1970;213(11):1902-1904.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

To the Editor.—

This letter from Dr. Simmons evokes our profound disagreement. Dr. Simmons suggests that a physician employing a drug in his practice in some way differing from the recommendations of the drug's labeling should submit to the FDA a "Notice of Claimed Investigational Exemption for a New Drug" (IND). His arguments to encourage this procedure are not persuasive.

The IND procedure, provided by regulations authorized by the Food, Drug, and Cosmetic Act, is a mechanism by which the manufacturer or comparable distributor of a new drug in interstate commerce may have the necessary testing performed to market the drug. There is no other legitimate purpose for the procedure. It is true that a manufacturer may already have a drug on the market and may submit another IND to prepare for some change in the conditions under which he sells the drug. He may propose a new dosage form—say . . . [Full Text PDF of this Article]

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