Insights
Notes on the US pathway.
Explainers for sponsors preparing a first submission. Written from practice, not from the guidance index.
- Clinical strategy
What an Early Feasibility Study asks of a first-time sponsor
An EFS is not a small pivotal and not a shortcut. It is a bargain with FDA: less complete data now, in exchange for a sponsor who shows it understands the risk.
- Quality systems
QMSR is in force. What changes for a small manufacturer
The 21 CFR 820 you remember is not the 21 CFR 820 an investigator will inspect against. What actually changed, and why startups are the most exposed.
- Submissions
Reading a deficiency letter: what FDA is actually asking
A deficiency letter is not a rejection. It is the agency telling you, in order, exactly what stands between your submission and a decision.
- Submissions
When a Pre-Submission pays for itself
FDA will tell you in writing what it expects before you spend on testing. Here is when to ask.
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