The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA, or ANDA.'' The draft guidance provides recommendations to industry and FDA staff regarding the content and submission procedures for use-related risk analyses, human factors validation study protocols and reports, threshold analyses, and comparative use human factors study protocols and reports.
Document
Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Contents of a Complete Submission for Threshold Analy...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
83 FR 49391
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications; Draft Guidance for Industry; Availability,” thefederalregister.org (October 1, 2018), https://thefederalregister.org/documents/2018-21243/contents-of-a-complete-submission-for-threshold-analyses-and-human-factors-submissions-to-drug-and-biologic-applications.