federal_register: 2018-21314

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2018-21314 Adaptive Designs for Clinical Trials of Drugs and Biologics; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Adaptive Designs for Clinical Trials of Drugs and Biologics." This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance describes the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial. The draft guidance will replace the 2010 draft guidance for industry entitled "Adaptive Design Clinical Trials for Drugs and Biologics." 2018-10-01 2018 10 https://www.federalregister.gov/documents/2018/10/01/2018-21314/adaptive-designs-for-clinical-trials-of-drugs-and-biologics-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2018-10-01/pdf/2018-21314.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Adaptive Designs for Clinical Trials of Drugs and Biologics." This document provides guidance to sponsors and applicants...  

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