FDA Official Recommends Firms Consult FDA Prior to eCTD Submissions

Drugmakers should consult with the FDA before drafting their first electronic common technical document (eCTD) submission to ensure the documentation is prepared properly and conforms to agency requirements, advises a Center for Drug Evaluation and Research (CDER) official.

The FDA has received approximately three dozen eCTDs in the last 18 months, according to Ginny Ventura of CDER's Office of Information, who spoke at the Drug Information Association's Electronic Document Management Conference in Philadelphia. During those 18 months, the agency has noticed some common mistakes in the submissions, which Ventura said range from missing information to improper formatting.

For more information about eCTDs, go to http://www.fda.gov/cder/regulatory/ersr/default.htm (http://www.fda.gov/cder/regulatory/ersr/default.htm) or write eSub@cder.fda.gov (mailto:eSub@cder.fda.gov).