About FDA

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

 

Topics Webpage First Published Last Updated
Field Alert and Biological Product
Deviation Reporting Regulations
May 1st, 2013  
NDA and ANDA Field Alert Reporting Regulations May 1st, 2013  

Form FDA 3331 Automated

Form FDA 3331 Automated May 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 Answers May 1st, 2013   
Detailed Instructions for Use of Form FDA 3331A Instructions for using the Form FDA 3331 Automated May 1st, 2013   
Forms Page FDA Forms May 1st, 2013  May 6th, 2013
ORA Monitors May 1st, 2013  
Central Document Room Regulations.gov May 1st, 2013   
Federal Register Notice Federal Register May 1st, 2013  

 

 

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

Page Last Updated: 04/27/2016
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