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U.S. Department of Health and Human Services

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PILOT- Form FDA 3331-Automated Pilot Program

FDA is launching a pilot program enabling manufacturers to electronically submit Field Alert Reports (FARs) to improve the speed and efficiency of reporting quality issues relating to the manufacture of FDA-approved drug products. The objective of this pilot program is to provide for simultaneous reporting to both FDA district offices and CDER, while determining the feasibility of transitioning from a PDF form to an electronic form. Currently, all FARs are submitted by firms to the Agency in PDF or hardcopy form. For more information please click on any of the below links

 

TopicsWebpageFirst PublishedLast Updated 
Field Alert and Biological Product
Deviation Reporting Regulations
May 1st, 2013 
NDA and ANDA Field Alert Reporting RegulationsMay 1st, 2013 

Form FDA 3331 Automated

Form FDA 3331 AutomatedMay 1st, 2013  May 6th, 2013
Notice to Industry-Benefits to Participation

Notice to Industry: FDA Launches Pilot Project for Electronic Submission of Field Alert Reports

May 1st, 2013 
Questions and AnswersMay 1st, 2013  
Detailed Instructions for Use of Form FDA 3331AInstructions for using the Form FDA 3331 AutomatedMay 1st, 2013  
Forms PageFDA FormsMay 1st, 2013 May 6th, 2013
ORA MonitorsMay 1st, 2013 
Central Document RoomRegulations.govMay 1st, 2013  
Federal Register NoticeFederal RegisterMay 1st, 2013 

 

 

 

 

 Document(s)WebpageFirst PublishedLast Updated
Field Alert and BiologicalMain Page  
Pilot Webpage