Episode 99- Who Really Ran the Study? The FDA Case That’s Shaking Trust in Preclinical Data

What if the safety data behind a drug… couldn’t be verified?

In Episode 99 of the Orange Pill Podcast, we break down a recent FDA Warning Letter that exposed a troubling “liaison” model, where a contract research company claimed ownership of studies it never actually conducted.

From falsified study directors to missing raw data, this case reveals how gaps in oversight can compromise the very foundation of drug development, and why sponsors can no longer rely on paper compliance alone.