federal_register: 2011-21972

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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
2011-21972 Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring." This guidance is intended to assist sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data. The guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities when conducting investigational new drug (IND) or investigational device exemption (IDE) studies. 2011-08-29 2011 8 https://www.federalregister.gov/documents/2011/08/29/2011-21972/draft-guidance-for-industry-on-oversight-of-clinical-investigations-a-risk-based-approach-to https://www.govinfo.gov/content/pkg/FR-2011-08-29/pdf/2011-21972.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring." This guidance is intended to assist sponsors in developing...  

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