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Frank E. Young, MD, PhD; Stuart L. Nightingale, MD

JAMA. 1988;260(2):247.

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

The Food and Drug Administration has initiated a new system for making available certain investigational drugs—for the treatment of desperately ill patients for whom there is no effective alternative therapy—prior to their approval for marketing. This system and the process involved in identifying and designating those drugs as "Treatment INDs" have been described previously.¹ As these drugs for certain patients with serious or life-threatening diseases become more available under the Treatment IND process, it is important for the Food and Drug Administration to directly inform the practitioner about the drugs and about the treatment protocols under which they may be used. Most important for physicians who may want to pursue use of one of these drugs for their patients is the need to provide and publicize a contact (eg, a telephone source) for further information on each drug, especially information on matters such as patient selection criteria and where . . . [Full Text PDF of this Article]

Author Affiliations
Food and Drug Administration Rockville, Md

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