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  1. Generic Drug User Fee Amendments

Improving the Quality of ANDA Submissions

FDA wants to hear from you! We are establishing a public docket to receive input and suggestions from the public on ways to improve the quality of abbreviated new drug applications (ANDAs) and associated amendments and supplements. Specifically, FDA is interested in hearing about difficulties sponsors are having developing and preparing their ANDA submissions.

 
FDA is also seeking input on how to best share suggestions for improving the quality of ANDAs with the generic drug industry. 
 
Improving the quality of ANDA submissions will result in more submissions accepted for filing, fewer amendments and easily correctable deficiencies (ECDs), and ultimately, more generic drug approvals.
 
FDA welcomes comments at any time, but we encourage submission of electronic or written comments to http://www.regulations.gov or Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 by March 24, 2014. 

 

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