PLR FAQ





My tables don’t look like they do in Word. Can I format my table (i.e., cell spacing etc) to reflect the way I want it to look?

Attributes for table elements are currently not supported by the standard stylesheet and thus only minimal formatting will be seen by the FDA when they view your label. It is stated that “SPL is used to communicate labeling content rather than the exact representation of drug information present in a typeset document. The table presentation in SPL is unlikely to exactly duplicate the presentation in word processed or typeset versions of the package insert”.
References: SPL Implementation Guide Release 4/July 2008
See http://www.fda.gov/oc/datacouncil/spl.html for any updates to the Implementation Guide. ----

My tables are in a format other than Word. Can I put an image of a table into the SPL?

[25-Aug-2008]
Avoid images of tables. The SPL reflects the content of labeling. An image is not searchable, and is not textual.

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  • Miscellaneous - Uncategorized


1. What if I have multiple ‘Initial U.S. Approval’ (§201.57(a)(3)) dates?


Multiple dates should not be listed for products with multiple formulations approved or licenses in different years. For these products, list the initial approval date of the new molecular entity, new biologic product, or new combination of active ingredients.


References: __
Labeling for Human Prescription Drug and Biological Products --- Implementing New Content and Format Requirements
See http://www.fda.gov/cder/regulatory/physLabel/default.htm for any updates to the guidance.
See http://www.fda.gov/OHRMS/DOCKETS/98fr/06-545.pdf for the Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, January 24, 2006. Effective June 30, 2006



Recent Major Changes

Links

Physicians Labeling Rule: http://www.fda.gov/cder/regulatory/physLabel/default.htm