Where in a drug/biologic application should an applicant include certification that financial arrangements of concern do not exist or the disclosure of those arrangements that do exist?
Where should the information be included in a device application? For drugs and biological product applications, applicants should include the financial certification/disclosure forms as part of item 19 (other) of the application. See form 356h. FDA is revising the current form 356h and upon completion of this revision, financial certification and disclosure information will become number 19 and (other) will become number 20. For device applications, applicants should submit the financial certification/disclosure forms according to the format outlined in the appropriate submission checklist. Q: What obligations do IND and IDE sponsors have regarding information collection prior to study start? A: The regulations, 21 CFR 312.53 and 21 CFR 812.43, provide that before permitting an investigator to begin participation in an investigation, the IND/IDE sponsor shall obtain sufficient accurate financial information that will allow an applicant to submit complete and accurate certification or
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