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# Draft Guide on eSubmission Data for BIMO Inspection Prep
- URL: https://www.fdaweb.com/draft-guide-on-esubmission-data-for-bimo-inspection-prep/
- Published: 2018-02-16T12:00:00.000Z
- Updated: 2026-09-14T23:23:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140785

*Federal Register* notice: FDA has made available a draft guidance entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions’’ along with a document called Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications. The documents describe and provide specifications for the electronic submission of certain data and information in standardized formats. The information is intended to be used by CDER and ORA in planning and conducting BIMO inspections. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-16/pdf/2018-03236.pdf?ref=fdaweb.com).