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U.S. Department of Health and Human Services

Drugs

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Labeling Frequently Asked Questions

Disclaimer:  These are general answers and may not be applicable to every product.  Each ANDA is reviewed individually.  This document represents the Office of Generic Drugs’s (OGD’s) current thinking on these topics.

  
1.   Why do we request Labeling QbR?
 
Labeling QbR is requested to facilitate labeling reviewers in locating information and to provide efficiency in the labeling review process.
 
2.    Should the applicable Labeling QbR questions be presented within the body of Module 1, 1.14, Labeling, of the relevant section, followed by sponsor’s answers?
 
Yes, please include all the applicable Labeling QbR questions in a separate folder  within the body of Module 1 followed by sponsor’s answers.
 
3.      If a question is not applicable to the sponsor’s application, should the question be deleted or unanswered?
 
Sponsor should never delete a Labeling QbR question.  Sponsor should answer as “Not Applicable” and include a brief justification. 
  
4.      Will Labeling QbR lead to longer review times?
 
Many of the current long review times result from applications that do not completely address all of the review issues and OGD must request additional information through the deficiency process.  The review process may be reduced with the use of the Labeling QbR template.
 
5.      Will additional information or instruction accompany the questions?
 
Wherever a hyperlink appears with a question the hyperlink may be followed to find additional information or instruction regarding that particular question.