This translates into agency review that is based more on science and less on conservative speculation, effecting shorter overall drug development times. Dr. Randy Levin , Associate Director for Electronic Review at the agency, presented FDA's goal of transitioning from customized to standardized electronic submissions. He acknowledged that change is not necessarily easy for FDA or industry, and that there is tremendous management support at FDA to reach this goal. He encouraged questions and suggestions from industry. The reviewers also provided recommendations to improving these submissions that were applicable to all disciplines.
Reviewers can exchange information with fewer delays.
Navigation tools and keyword searching save review time. Better consistency and quality of submissions enhances review efficiency. All reviewers have access to the entire submission. Use PDF with embedded font. Avoid scanned images since they are difficult to read.