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Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of the Comment Period

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability for ``Development of a Shared System Risk Evaluation and Miti...

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability for ``Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry,'' published in the Federal Register of June 1, 2018. The Agency has received a request for an extension of the comment period for the draft guidance.

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Federal Register Citation

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83 FR 44273

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“Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of the Comment Period,” thefederalregister.org (August 30, 2018), https://thefederalregister.org/documents/2018-18775/development-of-a-shared-system-risk-evaluation-and-mitigation-strategy-draft-guidance-for-industry-availability-reopenin.