Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry; Availability
What this record is not
Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions." The draft guidance document and BIMO Technical Conformance Guide provide specifications for the electronic submission of certain data and information in standardized formats. This information is used by FDA's Center for Biologics Evaluation and Research (CBER) in the planning of, and by FDA's Office of Regulatory Affairs (ORA) in the conduct of, BIMO inspections. The draft guidance addresses major (i.e., pivotal) studies used to support safety and efficacy claims in biologics license applications (BLAs) and new drug applications (NDAs) regulated by CBER, as well as certain supplemental applications containing new clinical study reports. This draft guidance, when finalized, will provide additional information regarding the format to be used for electronic submission of BLA and NDA content for the planning and conduct of CBER BIMO inspections, using the electronic Common Technical Document.
Abstract as published in the Federal Register.
READ THE FULL DOCUMENT
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.
Create a free account