Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 5, 2024
December 6, 2024
9135a75c-48b3-48bb-8340-09e33de8f931
Related Documents
Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for Industry
Guidance DocumentSeptember 24, 2025Center for Biologics Evaluation and Research
Potency Assurance for Cellular and Gene Therapy Products
Guidance DocumentDecember 27, 2023Center for Biologics Evaluation and Research
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method
Guidance DocumentOctober 17, 2024Center for Biologics Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox