The Pre-Product Startup and the FDA

A frequent question we get at YC is “when do I start thinking about the FDA Obviously, there is no single answer to such a complex question, but here are some basic rules of thumb for how to think about it.

FDA: Orientation for Early Stage Startups

One of the most common topics YC Bio founders ask us about is the US Food and Drug Administration (FDA), and the broader regulatory environment. As a starting point, we wanted to touch on some of the most important concepts bio founders should think about.