Resources from Deffai
FDA guides and templates.
Practical guides, playbooks, and templates for your FDA submissions.
What is FDA’s Tissue Reference Group?
A simple guide to who decides whether your tissue product is regulated solely under section 361 of the Public Health Service (PHS) Act, and where it lands inside FDA if it isn’t.
Read the guide361 HCT/P Warning Letters
How FDA actually enforces the HCT/P regulatory framework and where companies keep going wrong.
Read the analysisThe 361 Status Eligibility Playbook
The strongest case for eligibility is built long before the actual submission.
Read the guideThe TRG Submission Checklist
A successful submission effectively translates your strategy.
Get the templateThe Biologics Development Roadmap
How cell and gene therapy biological products moves from idea to licensed BLA
Read the guideFDA Milestone Meetings
A guide to the formal FDA meetings every cell and gene therapy program runs on, built on the framework that governs all drugs and biologics.
Read the guideThe INTERACT Meeting Playbook
Why and when to ask FDA for early advice on a novel biologic, and how to know you’re actually ready.
Read the guideThe INTERACT Checklist & Submission
How to create a focused INTERACT submission with the right questions
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