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GUIDANCE DOCUMENT

Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry February 2018

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-0481
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

This draft guidance describes the electronic submission of certain data and information in standardized formats, and supersedes the previously issued draft guidance for industry Providing Submissions in Electronic Format — Summary Level Clinical Site Data for CDER’s Inspection Planning. This guidance applies to electronic submissions of data and information from all major (i.e., pivotal) studies used to support safety and efficacy claims in new drug applications (NDAs), biologics license applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER), and supplemental applications containing new clinical study reports. It also applies when these data and information are submitted in certain investigational new drug applications (INDs) in advance of a planned NDA, BLA, or supplemental submission.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-0481.