Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010: Whether Human Research Studies Can Be Conducted Without an Investigational New Drug application.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.’’ This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an investigational new drug application (IND). The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required, and discusses a range of issues that, in FDA’s experience, have been the source of confusion or misperceptions about the application of the IND requirements.
http://www.gpo.gov/fdsys/pkg/FR-2010-10-14/pdf/2010-25851.pdf
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