Regulatory Open Forum

Hello, I have a question about submission of Promotional material.

We have an approved vaccine, and have created a promotional piece for  HCP s. It was submitted on FORM 2253, and identified as an "Electronic Detail Aid", intended to be supplied as a PDF file on a CD. There has been a request from Sales and Marketing to print out the PDF file and distribute the print version instead of as a PDF File. 

Does this need to be re-submitted as a new piece? The content and format are identical, it would just be printed instead of a PDF file. 

Thank you for any input you can provide. 

Hi Susan.

While I am not intimately knowledgeable of the vaccine industry and the regulations underlying it, I would think, logically that if the information and format is identical and the only true difference is print versus CD pdf file, then FDA should not be wasting time on reviewing the exact same piece of promotional literature twice.  However, I would suggest that the only thing that would fit this would be a print of the exact pdf file that was included to be reviewed.  Let's face it, what is the difference in whether the company prints a hard copy of the electronic file or if the HCP prints the same hard copy?  Logically there is no reason to expect that FDA would want to spend time reviewing in my opinion.  If the agency is expecting to review this information again, that would seem like a significant point of improving efficiency.  But as I said, I would be absolutely certain that the print copy is identical to the CD copy because if it were not, then you at least theoretically could get some negative responses from FDA.