Labeling Requirements for Human Prescription Drug and Biological Products

OMB 0910-0572

OMB 0910-0572

The information collection supports agency regulations governing the content and format of labeling for human prescription drug and biological products. Respondents to the collection are sponsors of new drug and biological product applications.

The latest form for Labeling Requirements for Human Prescription Drug and Biological Products expires 2022-01-31 and can be found here.


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