PASS (Post-Authorization Safety Study)
What is it?
A PASS is a study carried out after a medicine is already approved, designed to gather more information about a safety concern, characterize the effectiveness of a risk-minimization measure, or measure how well a known risk is actually being managed once the drug is in routine use. It can be imposed by a regulator as a condition of approval, or run voluntarily by the manufacturer.
A PASS isn't re-litigating whether the drug works. That question was answered pre-authorization. It exists purely to sharpen the picture on safety, using real-world use patterns that trials simply can't replicate.
Common Misconceptions
"A required safety study after approval? That must mean regulators weren't satisfied the first time."
Plenty of approved medicines carry a PASS commitment as standard practice, especially newer ones or those with a more complex risk profile. It's a planned continuation of monitoring, not a sign the original approval was shaky.
