How can I get a copy of a postmarketing study commitment protocol or final report?
Protocols and final reports can be requested either directly from the applicant or from FDA under the Freedom of Information Act (5 U.S.C. 552) (FOIA). Because information contained in these documents may be proprietary in nature, your request may be denied or information in the documents may be redacted. Certain information regarding postmarket studies and clinical trials can also be obtained from ClinicalTrials.gov.
