Blog
Announcements and updates from the Arca team
Orange Book vs Purple Book: A Practical GuideCompare Orange Book vs Purple Book records for reference products, patents and exclusivity, with an insulin example to guide your team's review.
FDA's First AI Warning Letter: The Model Wasn't the ProblemFDA’s first AI warning letter was really about basic GMP failures, not AI.
What FDA Warning Letters Stopped Being AboutCOVID displaced manufacturing enforcement for three years. Compounding took its place.
We Read 445 FDA Rejection Letters. Most Are About the Factory.Of 445 FDA rejection letters, 236 cited manufacturing problems without a clinical deficiency.