Blog
Announcements and updates from the Arca team
How to Use AI to Monitor Competitor Drug Labels and ApprovalsUse AI to catch competitor label changes, approvals and CRLs as FDA and EMA publish them, then map each change to your own claims and labeling.
How to Use AI for Medical Device Post-Market SurveillanceAI can code complaints, trend rates, watch similar devices across regulators and draft PSUR inputs. Reportability and risk decisions stay with your team.
Model Routing Made Our Customers' AI Work 76% CheaperArca sends each AI request to the smallest model that handles it well. Over 30 days, customers' AI work cost 76% less than it would have on the Max tier.
Introducing Reg Affairs BenchA benchmark of real regulatory affairs deliverables, comparing Arca with the frontier model APIs it runs on.
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 warning letter to mention AI cites insects in the production area, untested components and no quality unit. The AI finding was the smallest one.
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.