Regulations.gov document

Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of…

Other · FDA-2018-D-0481 · posted Dec 9, 2024

Key facts

Document ID FDA-2018-D-0481-0012
Title Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions; Guidance for Industry
Document type Other
Subtype Guidance
Agency FDA
Docket FDA-2018-D-0481
Posted Dec 9, 2024
Comment period opens Dec 9, 2024

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