Can FDA have access to documents related to financial disclosure or certification documents during an inspection?
Yes, FDA has the authority to have access to and to copy documents supporting an applicant’s certification or disclosure statement submitted to the agency in a marketing application. Regulations implementing sections 505(i), 519, and 520(g) of the Act require sponsors to establish and maintain records of data (including but not limited to analytical reports by investigators) obtained during investigational studies of drugs, biological products, and devices, that will enable the Secretary to evaluate a product’s safety and effectiveness. Under 54.6, applicants must retain certain information on clinical investigators’ financial interests and permits FDA employees to have access to and copy them at reasonable times. Q: What kind of documentation is necessary for manufacturers to keep in case questions about certification and/or disclosure arise? A: To the extent that applicants have relied on investigators as the source of information about potentially disclosable financial interests in
