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  1. Electronic Regulatory Submission and Review

Drug Classification

Drug Classification

FDA Data Element Number. None.

CDER Data Element Number. C-DRG-00101

Data Element Name. Drug Classification.

Description. This standard provides for a mechanism for classifying all drugs from the Investigational New Drug (IND) stage of development onward.

Source. In process - CDER Drug Classification Subcommittee has reviewed various drug classification databases, and has recommended that USAN and AHFS be the primary candidates to develop this standard. Indication may supersede the need to progress further in the classification area.

Relationship.

FDA Specifications.

CDER Specifications.

FDA Approved Date.

CDER Approved Date.

FDA Revised Date.

CDER Revised Date.

Data Values.