CDER Small Business Update

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business

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Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan  

  

On December 26, FDA published a notice in the Federal Register announcing the availability of the Generic Drug User Fee Act (GDUFA) Information Technology (IT)Plan.  The plan explains FDA’s approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the GDUFA Performance Goals and Procedures for Fiscal Years 2013 through 2017. 

FDA is requesting comments from industry and other interested stakeholders as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.