Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: up to 120 Years (Child, Adult, Senior) Sexes Eligible for Study: Male Accepts Healthy Volunteers: No Criteria GENERAL INCLUSION CRITERIA
Therefore, a study record that (1) does not list "United States" (or a . territory) for the Facility Information/Country data element, (2) lists "No" for the . Food and Drug Administration IND or IDE data element, and (3) lists "No" for the Product Manufactured in and Exported from the . data element, would indicate that a studied drug or biologic product is not "subject to" section 505 of the FD&C Act or section 351 of the PHS Act. For such a study, the responsible party would answer "No" to the Studies a . FDA-regulated Drug Product data element and the study would not be considered an applicable drug clinical trial. Note that even if the drug or biologic product being studied had previously been approved by the . FDA under section 505 of the FD&C Act or section 351 of the PHS Act for marketing in the ., that responsible party would list "No" for the Studies a . FDA-regulated Drug Product data element because the particular drug or biological product used in that study is not subject to those sections of the FD&C Act or PHS Act.