federal_register: 2012-30510

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2012-30510 Draft Guidance for Industry on Providing Submissions in Electronic Format-Summary Level Clinical Site Data for Center for Drug Evaluation and Research's Inspection Planning; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Submissions in Electronic Format--Summary Level Clinical Site Data for CDER's Inspection Planning." The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site (summary level clinical site dataset). The summary level clinical site dataset is intended to facilitate use of a risk-based approach to timely identification of clinical investigator sites for onsite inspection by FDA during the review of marketing applications. This draft guidance describes a recommended electronic format for the summary level clinical site dataset to be submitted voluntarily in new drug applications (NDAs), biologics licensing applications (BLAs), and NDA and BLA supplemental applications submitted to FDA's Center for Drug Evaluation and Research (CDER). 2012-12-19 2012 12 https://www.federalregister.gov/documents/2012/12/19/2012-30510/draft-guidance-for-industry-on-providing-submissions-in-electronic-format-summary-level-clinical https://www.govinfo.gov/content/pkg/FR-2012-12-19/pdf/2012-30510.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Submissions in Electronic Format--Summary Level Clinical Site Data for CDER's Inspection Planning." The draft guidance is...

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