From Genentech – Oncology R&D Division Template by David Nagy · Templates

📂 SECTION 5: 📝 Regulatory & Submission

Published

📄 FDA Interaction Log

  • Meeting summaries
  • Feedback

📄 IND / NDA Documentation

  • Key documents
  • Submission timeline

📄 Risk Mitigation Plans

  • Safety concerns
  • Regulatory strategies