Ing. Helmut Schütz

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FDA

Self-Identification of Generic Drug Facilities, Sites, and Organizations

On 22 Aug 2012 the FDA published a  draft guidance and a related  Questions & Answers document.

This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how the Food and Drug Administration (FDA or Agency) will implement an identification requirement contained in the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA.
As required by GDUFA, FDA will issue a self-identification requirement notice in the Federal Register in the coming weeks explaining that human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA within 60 days. The notice will also list the self-identification information that must be submitted.
FDA is issuing this guidance to help human generic drug facilities, sites, and organizations prepare to meet the self-identification requirement. Topics discussed in this guidance include:

• which types of generic facilities, sites, and organizations are required to self-identify;
• what information is requested;
• what technical standards are to be used for electronically submitting the requested information; and
• penalty for failing to self-identify.

The guidance also explains generally which types of generic facilities, sites, and organizations will be required to pay user fees.

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Update

Final guidance of September 27, 2016 and Q&A document of November 18, 2016.