FDA Officials Issue Call for More Electronic Submissions
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.
Echoing their recent call for more industry involvement in the esubmissions initiative, Stephen Wilson, acting director of the FDA's Office of Business Process Support in the Center for Drug Evaluation and Research (CDER), and Randy Levin, director for health and regulatory data standards, assured Drug Information Association conference attendees that the agency was ready for the program and that leveraging it would speed the processing of submissions.
Medical officer and reviewer Lesley-Anne Furlong told attendees, "I like electronic submissions." In addition to their portability, Furlong said that as a reviewer she values their "power to explore data with incredible speed."
FDA reviewers also like:
Lots of bookmarks and hyperlinks; Ability to cut and paste; Ability to search; and Column headers that stay the same for the same data.
She acknowledged that some reviewers are not as enthusiastic about the new learning curve challenges associated with esubmissions. Reviewers have to learn new software and there is sometimes an overall "resistance to change," she noted. But she implored attendees to send investigational new drug and new drug applications electronically. "We need to get good at this together," Furlong added.
"Not every [reviewer] is like Lesley and ready to embrace" esubmissions, admitted Gary Geinsinger, director of review technology at CDER. But he also urged regulated life sciences companies to continue their increased adoption of esubmissions -- even if they sense a little reviewer resistance.
"This is agency policy" to move toward eubmissions, he noted. He also said there was no need to fear that if you deliver a submission electronically it will "harm" your approval chances with your reviewer. He also advised letting his office know in advance that you will be submitting electronically so they can work to deliver some in-house training for your FDA review team. -- Michael Causey