Radioactive Drugs for Certain Research Uses; Public Meeting; Reopening of Comment Period

الملخص

The Food and Drug Administration (FDA) is reopening until July 11, 2005, the comment period on the questions raised and issues addressed in the notice of public meeting, published in the Federal Register of October 5, 2004 (69 FR 59569), on the use of certain radioactive drugs for research purposes without an investigational new drug application (IND) under the conditions set forth in FDA regulations. We are taking this action in response to requests to extend the comment period and to allow additional time to review agency guidance on a related matter.