federal_register: 2016-13167

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2016-13167 Individual Patient Expanded Access Applications: Form FDA 3926; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Individual Patient Expanded Access Applications: Form FDA 3926." The guidance describes Form FDA 3926 (Individual Patient Expanded Access-- Investigational New Drug Application (IND)), which is available for licensed physicians to use for expanded access requests for individual patient INDs. Individual patient expanded access allows for the use of an investigational new drug outside of a clinical investigation, or the use of an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS), for an individual patient who has a serious or immediately life-threatening disease or condition when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. Form FDA 3926 provides a streamlined alternative for submitting an IND for use in cases of individual patient expanded access, including for emergency use. This guidance finalizes the draft guidance issued in February 2015. 2016-06-03 2016 6 https://www.federalregister.gov/documents/2016/06/03/2016-13167/individual-patient-expanded-access-applications-form-fda-3926-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2016-06-03/pdf/2016-13167.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 guidance for industry entitled "Individual Patient Expanded Access Applications: Form FDA 3926." The guidance describes Form FDA 3926 (Individual Patient Expanded...  

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