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dear all,
we would like to a bioequivalence study of cytotoxic drug on cancer
patients.do we have to submit form no.1571 of USFDA for this study
because of its BIO-IND category?then who should fill this form?sponsor
or principal investigator?
usually we submit form no.1572.is not it? please clarify.
thanks and regards,
Muhiyideen
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Muhiyideen,
From the FDA web site:
Form FDA 1572: is a form that is completed by each investigator prior
to participating in an investigational new drug study. This form
should be updated during the course of an investigation if any
information on the form changes.
Form FDA 1571: It is the responsibility of a sponsor to complete the
form FDA 1571. However, if the investigator is the IND holder, she/he
would have to assume the sponsor's responsibility, and therefore
complete the form.
Instructions for completing the 1571 and 1572 can be found at
http://www.fda.gov/cder/forms/1571-1572-help.html
The actual forms can be found at
http://www.fda.gov/opacom/morechoices/fdaforms/cder.html.
Frank Bales, Ph.D.
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