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The FDA wants to create an electronic network to gather and share medical product safety information with healthcare professionals and patients, the agency announced.
Creating effective bookmarks and hyperlinks in any esubmission program begins in the MS Word document and continues with rendering the document to PDF, Octagon Research Solutions experts told PIR recently.
Carefully defining the scope of an esubmissions program and having cross-functional agreement is "vitally important," Octagon Research Solutions Principal Consultant Gareth Williams told PIR last week.
Wyeth Pharmaceuticals is expanding its esubmission program and capabilities working with Octagon Research Solutions, Octagon President Kirk Gallion told PIR Aug. 11.
Regulated companies that had been nervous about sending esubmissions to the FDA should applaud the agency's new tool to help it receive and process electronic drug, biologic and device applications in an effort to keep up with industry's use of internet submissions, InfoStrength President Rita Geiger told PIR last week.
Large drug manufacturers continue to be the big drivers behind the broadest electronic document control (EDC) initiatives, as evidenced by several presentations at the recent DIA conference in Philadelphia.
The FDA’s Center for Biologics Evaluation and Research (CBER) earlier this month issued a guidance on how manufacturers of biologic products should submit their lot release protocols in electronic format to CBER’s Product Release Branch.
The size of the market for eclinical trials was $210 million in 2004 and will increase to $357.4 million in 2011, according to a new report published by consulting firm Frost & Sullivan.
Wyeth can more smoothly prepare esubmissions of pharmacogenomic clinical data to the FDA under its recently expanded agreement with Expression Analysis.