FDA takes questions at DIA

The second day of the annual DIA show offered attendees a chance to pick the brains of high-ranking FDA officials. At two separate sessions, FDA experts spoke about trends affecting the industry and took questions from the audiences about specific FDA issues. And of course there were a variety of technology announcements from exhibitors at this year's show. Here's a run-down of yesterday's highlights. - Maureen

  • At both sessions, there were a variety of questions regarding the FDA's plans for generic biologics. Bob Yetter, Associate Director Review Management at CBER/FDA, clarified the key issue in approving a regulatory pathway for biosimilars. "The first challenge to a pathway is getting regulations in place that will actually define what biosimilars are," he observed. "What is the scope of biosimilars? Is everything that is a biologic included? Where do vaccines lay in this approach?" Answering these questions is the first step that needs to be taken. In a separate session Steven Kozlowski, director of the FDA's Office of Biotechnology Products, said that the FDA will learn from the EMEA because the European agency is slightly ahead of the U.S. when it comes to biosimilars. The FDA will focus on quality, safety and efficacy for as it looks to approve generic versions of biotech drugs.

  • The other FDA topic du jour is comparative effectiveness. With the movement to control drug prices gaining steam, session attendees wanted to know what to expect from the FDA in the coming years. "Historically, the FDA hasn't looked at economics of drugs. That won't change unless something comes from above." The FDA speakers agreed that competitive effectiveness isn't about politics; it's about what's best for patients. "You're going to have to be effective to be competitive," noted Kozlowski.

  • A trend among supplier announcements at DIA--in addition to that of a standards emphasis--has been solutions for end-to-end clinical trial coverage. One such announcement has been made by TrackWise software maker Sparta Systems, which has launched TrackWise Clinical Quality Management Solution. It says the offering streamlines the oversight of clinical trial business processes and helps ensure compliance with global regulatory standards. 

  • Service provider US Oncology has implemented the Oracle Database as part of a Java-based electronic health record system. The system, called iKnowMed, provides EHR access to some 800 oncologists across 468 affiliated locations, Oracle announced at DIA. Report

  • CoMotion Trials, a version of the Viz CoMotion software developed by military contractor General Dynamics for battlefield information sharing, is being demonstrated at the show. Viz is part of General Dynamics C4 Systems. Array BioPharma is currently using the software, the company says. Report

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