Did You Know...

That if you are submitting your eCTD to the FDA via the Electronic Submission Gateway, you should be providing a machine readable version of your application form?

This will assist the automation of submission receipt by the FDA. These "fillable forms" can be found at the following webpage: http://www.fda.gov/opacom/morechoices/fdaforms/default.html.

If your company is not ready to submit using electronic signatures, the FDA would prefer that you submit the machine readable version of the form unsigned and then also provide a scanned PDF of the form with signature. The file names for these forms should be very simple and direct, for example: 356h.pdf and 356h-signed.pdf. If you require a continuation or addendum sheet, that can also be provided as a separate PDF (356h-addendum.pdf).

You may note that these machine readable forms are password protected, which does not conform to ICH specifications. This is permissible by the FDA for the machine readable forms.

If you have any questions or would like more information, please see Datafarm™'s website (www.datafarminc.com) or email info@datafarminc.com.

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