| 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 | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| 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. | ||||||||||||||||||||||||