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How can I obtain a copy of a PAS protocol or final report?

April 26, 2017copy final obtain PAS Protocol report

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How can I obtain a copy of a PAS protocol or final report?

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Protocols and final study reports can be requested either directly from the applicant or from FDA under the Freedom of Information Act (5 U.S.C. 552) (FOIA). FDA will comply with the requirements of 21 CFR Part 20 on the disclosure of information.