federal_register: 2012-3956

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2012-3956 Draft Guidance for Industry on Providing Submissions in Electronic Format-Standardized Study Data; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Submissions in Electronic Format--Standardized Study Data." This draft guidance establishes FDA's recommendation that sponsors and applicants submit nonclinical and clinical study data in a standardized electronic format. The draft guidance recognizes that standardized study data promotes the efficient review of this information. The purpose of this draft guidance is to promote the use of data standards for study data, and increase the number of standardized study data submissions to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. 2012-02-21 2012 2 https://www.federalregister.gov/documents/2012/02/21/2012-3956/draft-guidance-for-industry-on-providing-submissions-in-electronic-format-standardized-study-data https://www.govinfo.gov/content/pkg/FR-2012-02-21/pdf/2012-3956.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Submissions in Electronic Format--Standardized Study Data." This draft guidance establishes FDA's recommendation that sponsors...

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