2005D-0385 Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
FDA Comment Number : EC1
Submitter : Mr. Christian Roussel Date & Time: 10/13/2005 12:10:15
Organization : Mr. Christian Roussel
Category : Drug Industry
Issue Areas/Comments
I totally agree that the use of electronic means needs to be encouraged by FDA. However, I would suggest to precisely define the type of electronic means in the guidance document. In terms of information content safety, the use of not-editable electronic formats, such as scanned PDF, should be enforced over editable Word emails.