BLA Filing Checklist
BLA Filing Checklist
General Items
- Conduct a final review of the entire submission
- Ensure all confidential information is protected
- Prepare for potential audits or inspections
Pre-Filing Preparation
- Gather all required documents
- Complete Form 356h - Application for Biologics License
- Compile product information and specifications
- Collect manufacturing process details
- Prepare labeling and packaging information
- Conduct stability studies
- Prepare safety and efficacy data
- Compile preclinical and clinical study reports
Regulatory Compliance
- Ensure compliance with FDA regulations
- Review ICH guidelines for biopharmaceuticals
- Confirm adherence to Good Manufacturing Practices (GMP)
- Check for patent and exclusivity considerations
- Ensure all fees are paid
Submission Process
- Create an electronic submission (eCTD format) or paper copy
- Verify all documents are complete and correctly formatted
- Submit the application to the FDA
- Send notifications to relevant stakeholders
- Track submission status and respond to any queries
Post-Filing Activities
- Prepare for potential FDA review meetings
- Gather additional requested information promptly
- Plan for post-marketing studies if required
- Monitor communication from the FDA regarding application status
Generated from Panda Checklist
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