FDAnews Drug Daily Bulletin

FDA ENCOURAGES ELECTRONIC SUBMISSIONS FOR ORPHAN DRUGS

April 10, 2006
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The FDA wants manufacturers of orphan drugs and devices designated for humanitarian use to make regulatory submissions in an electronic format, according to a draft guidance. The document describes the two methods by which such esubmissions can be made to the Office of Orphan Products Development (OPD).

The first is fully electronic, through the FDA's "electronic submission gateway." The second is through the use of physical media, such as CD-ROMs, accompanied by a signed paper cover letter. The guidance provides recommendations for the formatting and organization of these submissions. The all-electronic format uses the FDA's electronic gateway -- http://www.fda.gov/esg/ (http://www.fda.gov/esg/) -- to automatically forward submissions to the correct office.

To view the guidance, "Providing Regulatory Submissions in Electronic Format -- Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions," access http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0128-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0128-gdl0001.pdf).