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March 10, 2017
In the latest Director’s Corner podcast, “Moving Forward in 2017,” Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER) detailed the center’s priorities for 2017. Woodcock stated that the center’s first priority is improving and implementing Informatics Process Management across the center.
As part of the implementation, CDER has set up a governance board, Bio Informatics Governance, which includes a data standards effort and representatives of the standards boards, the change control boards, process control boards, process governance, and information technology. “Now we’ve already implemented the platform in the Generic Drug Review process and in other small processes around the center. We hope in October to be implementing the platform in some parts of the new drug review process and we hope to keep building on that. But, this requires discipline, it requires that we do have change control boards and governance boards over data, over process standards and that we standardize our processes so they can be automated,” Woodcock said.
Implementing provisions of the 21st Century Cures Act is the center’s second priority. CDER has performed an analysis of the provisions to determine which ones CDER is responsible for and what timelines and deliverables are needed for each. “And we’re not finished with [the analysis], but as soon as we get close we’re going to have to put together working groups and really start making this happen,” she stated.
Woodcock also plans to provide technical assistance to the reauthorization of various user fee bills, stating, “Another priority for me personally, is the work I plan to do with the new drug review program in the coming year. We’re undergoing a process to more or less re-invent, reimagine, refresh, or reinvigorate the new drug review process.”
Continuing to work on the opioid epidemic, modernizing manufacturing facilities, and drug compounding are among the center’s other priorities for the year. “We look forward to another busy and productive year in which we continue to assure that Americans have access to safe, effective and affordable drugs,” Woodcock stated.