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 more361 HCT/P Warning Letters
How FDA actually enforces the HCT/P regulatory framework and where companies keep going wrong.
Read moreThe 361 Status Eligibility Playbook
The strongest case for eligibility is built long before the actual submission.
Read moreThe TRG Submission Checklist
A successful submission effectively translates your strategy.
Read moreThe Biologics Development Roadmap
How cell and gene therapy biological products moves from idea to licensed BLA
Read moreThe 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 moreThe INTERACT Checklist & Submission
How to create a focused INTERACT submission with the right questions
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