federal_register: 2019-04815

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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
2019-04815 Enrichment Strategies for Clinical Trials To Support Demonstration of Effectiveness of Human Drugs and Biological Products; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products." The purpose of this guidance is to assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate effectiveness (and in some cases safety) of human drugs and biological products. This guidance defines several types of enrichment strategies, provides examples of potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials. This guidance finalizes the draft guidance entitled "Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products" issued on December 17, 2012. 2019-03-15 2019 3 https://www.federalregister.gov/documents/2019/03/15/2019-04815/enrichment-strategies-for-clinical-trials-to-support-demonstration-of-effectiveness-of-human-drugs https://www.govinfo.gov/content/pkg/FR-2019-03-15/pdf/2019-04815.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 final guidance for industry entitled "Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products." The...  

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