Principal+Display+Panel

Principal Display Panel - Validation Rules
[13-Jan-2010]

Subject:
Principal Display Panel, Carton image, Label image, PDP

Question:
Principal Display Panel (carton, label) - we have three representative samples. How many Principal Display Panel sections should there be?

Answer:
Each representative sample image for a different strength and formulation should be in its own Principal Display Panel major section.

Reference(s) :
//(e-mail sent by SPL group at FDA)//

[01-Nov-2009]

Subject:
Principal Display Panel, Carton image, Label image, PDP

Question:
Principal Display Panel (carton, label) - where is it placed in the SPL?

Answer:
Due to the receipt of several SPL documents submitted via the eList system with incorrect placement or omission of images of the representative sample of carton/container label(s) in the appropriate SPL content of labeling (major, not subsection) section identified as "Package.Label Principal Display Panel," a new technical validation procedure has been added. The validation procedure is: "There must be a section with the code 51945-4 (carton/container label)." The code "51945-4" is the LOINC associated with the (major) section heading "Package.Label Principal Display Panel."

Reference(s) :
//(Validation rule e-mail sent by SPL group at FDA)//

Subject:
Image Size

Question:
Is there a limit on file size for a JPG (JPEG) submitted in an SPL?

Answer:
Due to the receipt of several listing SPL documents submitted via the eList system with image file sizes over 1 MB, a new technical validation procedure has been added. The validation procedure is: The size of each image file referenced in a listing SPL files should be under 1 MB in size. In addition, please ensure that the images can be viewed on a computer screen without scrolling. Also, ensure that you are sending actual jpeg files and not another type of image file which has a file name with a file extension inappropriately replaced with "jpg."

Reference(s) :
//(Validation rule e-mail sent by SPL group at FDA)//