In a Word Document:
Greetings,
Here is feedback regarding your recent SPL submission:
Core ID: ciXXXXXXXXXXXXX.XXX@llnap21_te
Errors/Comments:
- In the product data elements section, the basis of strength should be the active moiety (it is also incorrect on the label).
If you would like test your SPL file prior to submitting to FDA, use the SPL document validator accessible from this web page: http://www.fda.gov/ForIndustry/DataStandards/ucm155514.htm.
NOTE: This validator is NOT connected to the FDA database and therefore, only detects ~95% of the technical errors.
Please contact us at spl@fda.hhs.gov if you have any questions or comments regarding this notification.
Lonnie Smith
Policy Analyst
Structured Product Labeling Team
FDA Data Standards Council
Whenever you see an error that refers to the basis of strength and active moiety association, the best way to correct this error is to check the Active Ingredient-Active Moiety Relationship/Basis of Strength Excel spreadsheet provided by the FDA on their Structured Product Labeling Resources page: (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm)
Comments
0 comments
Please sign in to leave a comment.