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  1. Development & Approval Process (CBER)

Compliance Actions on Biologics Advertising & Promotional Labeling

Compliance Actions on Biologics Advertising & Promotional Labeling

A Warning Letter is an informal, advisory correspondence, issued to achieve voluntary compliance and to establish prior notice. 

An Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of regulatory significance for a Warning Letter.

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