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U.S. Department of Health and Human Services

Drugs

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eCTD Submission Waivers

As of 1/1/08, sponsors submitting electronically are required to send new NDA, IND, ANDA, BLA, Annual Report and DMF submissions in eCTD format to CDER (refer to Memo 33 in the Electronic Submissions Public Docket number 92-0251).   NDA and ANDA original and supplemental applications that are under active review at the time of the deadline are not subject to the conversion.  Paper is still acceptable as an alternative to electronic submission.
Waivers are available for those sponsors who would like to submit electronically, but are unable to do so in eCTD format by the deadline.  The above-mentioned Memo 33 in the public docket contains instructions on obtaining a waiver.
Memo 33 instructs sponsors receiving waivers to prepare their submissions in accordance with the previous guidances which have been withdrawn. For your convenience, links to the guidances are below.  Note:  These guidances are for references purposes for those who have received waivers, and not for any other use.