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Post-Market Studies: Even With New Powers, FDA Relies On Firms’ Judgments

Executive Summary

BOSTON - When it comes to setting deadlines for completing post-marketing safety studies, industry has the expertise, Office of New Drugs Deputy Director Sandra Kweder told the Drug Information Association meeting on June 24

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Post-marketing status to be posted

FDA will post the status of a backlog of post-marketing study commitments in a Federal Register notice this month, CDER Director Janet Woodcock said at an Oct. 15 Drug Safety Conference sponsored by FDA, DIA and PhRMA. The agency contracted with Booz Allen Hamilton to assist in updating the post-marketing commitments database, and is working to "review the outstanding commitments to decide which ones need to be released and which ones need to be renegotiated," FDA Office of New Drugs Director John Jenkins said in July (1"The Pink Sheet," July 14, 2008, p. 11). A new Web site for safety information will include the required post-market commitments, Woodcock said

Post-marketing status to be posted

FDA will post the status of a backlog of post-marketing study commitments in a Federal Register notice this month, CDER Director Janet Woodcock said at an Oct. 15 Drug Safety Conference sponsored by FDA, DIA and PhRMA. The agency contracted with Booz Allen Hamilton to assist in updating the post-marketing commitments database, and is working to "review the outstanding commitments to decide which ones need to be released and which ones need to be renegotiated," FDA Office of New Drugs Director John Jenkins said in July (1"The Pink Sheet," July 14, 2008, p. 11). A new Web site for safety information will include the required post-market commitments, Woodcock said

Chart: Long-Term Commitments: The First Mandatory Post-Marketing Trials

Long-Term Commitments: The First Mandatory Post-Marketing Trials

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