federal_register: 2015-31690

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2015-31690 Safety Assessment for Investigational New Drug Application Safety Reporting; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled "Safety Assessment for IND Safety Reporting." The draft guidance provides recommendations to sponsors on developing a systematic approach to investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND. This draft guidance is a follow-on to the guidance for industry and investigators entitled "Safety Reporting Requirements for INDs and BA/ BE Studies" that provides recommendations for how sponsors of INDs can identify and evaluate important safety information that must be submitted to FDA and all participating investigators, including a recommendation that sponsors develop a safety assessment committee. 2015-12-17 2015 12 https://www.federalregister.gov/documents/2015/12/17/2015-31690/safety-assessment-for-investigational-new-drug-application-safety-reporting-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2015-12-17/pdf/2015-31690.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled "Safety Assessment for IND Safety Reporting." The draft guidance provides recommendations to sponsors on developing a...

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