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Success in moving investigational new drug (IND) projects toward adopting the electronic common technical document (eCTD) is more about collaboration than technology, experts said at a recent industry gathering.
Authoring standards can minimize problems and unexpected glitches such as inconsistent document formats, cost overruns and staff burnout when putting together electronic submissions, experts said last month at a Drug Information Association (DIA) conference.
While a small percentage of FDA reviewers may find it hard to switch from paper to electronic submissions, the bulk of them are excited about the possibilities and anxious to encourage industry to participate, FDA officials said.
More companies are beginning to accept the electronic common technical document (eCTD), and it is showing good signs of progress, but it "still has a long way to go," an FDA official said.
Adoption of the electronic common technical document (eCTD) is growing quickly as firms recognize that it makes their lives easier to file something once for different regulatory bodies, but industry may not fully embrace the technology until it is convinced that it will speed esubmissions to the FDA, expert Kim Nitahara told PIR last week.
With new regulations expected later this year requiring esubmission of postmarketing adverse events reports, an FDA official said last week that the agency feels its pilot program is "moving in the right direction" as industry embraces the benefits of the technology.
Regulated life sciences firms that want to realize the speed and efficiency promised by electronic common technical document (eCTD) reporting should make use of the FDA's testing program, agency officials said last week at an online "Town Hall" meeting sponsored by the Drug Information Association.