Built by people who file.
FDA Radar is published by Regulatory Leadership Partners, a regulatory affairs consultancy for the life sciences. That parentage is not a footnote; it is the design. Anyone can scrape openFDA — the APIs are free and public. What cannot be scraped is knowing that a guidance change means your usability report needs a new section if your 510(k) is in draft, and that it means nothing if you’re post-market. That judgment is written into every recommendation by someone who has done the filing, and it is the entire reason this product exists.
The product was born from a simple observation about the tools available to a regulatory team of one to five people: the enterprise platforms cost six figures and a sales cycle, the free option is a Google Alert and a colleague who forwards things, and nothing in between watches your specific products. FDA Radar is the in-between, built deliberately: personalised monitoring, expert review on everything, self-serve, priced (eventually) for the team the enterprise vendors can’t see.
How we work
- Public data, honestly labelled. Everything we monitor is public FDA output; the value is filtering and judgment. We publish what we cover and what we don’t.
- A person in the loop, permanently. Not scaffolding until the model improves — the review is the product. See the editorial standards.
- Corrections in public. When we get one wrong, the item says so, dated, forever.
The family
FDA Radar is part of a small estate of regulatory properties — Regulatory Leadership for consulting engagements, and sibling publications for regulatory news and education. They share one taxonomy, which is why a change FDA Radar flags can be connected to a consultant who has actually filed against it.
Talk to us
hello@regulatoryleadership.com — read by a person, answered by the same one.