federal_register: 2012-28149

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-28149 Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed." The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed in order to assure the protection of the rights and welfare of human subjects in clinical investigations. 2012-11-20 2012 11 https://www.federalregister.gov/documents/2012/11/20/2012-28149/draft-guidance-for-irbs-clinical-investigators-and-sponsors-irb-responsibilities-for-reviewing-the https://www.govinfo.gov/content/pkg/FR-2012-11-20/pdf/2012-28149.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research...

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