Definition

In the US, a submission to an approved NDA or BLA to request a change (e.g. new indication, manufacturing change). Prior Approval Supplement (PAS), CBE-30, or CBE-0 depending on change type.

Example

A new indication typically requires a PAS; certain manufacturing site changes may be CBE-30 (30-day supplement).

Regulatory source

21 CFR 314.70, 314.72; 21 CFR 601.12

Common mistakes

Using the wrong supplement type or implementing before approval when required.

Inspector question

How do you determine supplement type and ensure approval before implementation where required?

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