The reorganization of the FDA’s Office of New Drugs will help support the modernization of new drug reviews, Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research told attendees of RAPS’ Regulatory Convergence on Thursday.
She said the plan is to begin restructuring the premarket safety review process and then move into the investigational new drug (IND) application process.
By frontloading a lot of the activities, there will be more time to work out any issues with the company earlier, she said. Postmarket safety will also change with the introduction of new data sources, she said, noting the FDA is looking at its internal processes and how it manages signals.
As far as the OND reorganization goes, Woodcock noted that a new virtual policy office is in the works to continue putting out bulleted guidance documents. OND is also looking to centralize project management, which currently resides within the divisions, to make processes more uniform and repeatable.
Woodcock previously said her goal is to develop a common review template that will be used by all OND review divisions and enhance the office’s IT capabilities to make it easier for staff to access information generated during reviews.
Another part of the reorganization is to “flatten the organization,” she said, noting that some divisions have gotten “very big,” and those will be better fitted into offices that reflect a better synergy across divisions.
OND is also looking to set up a regulatory science working group to look at patient reported outcomes, biomarkers and bioinformatics, among other multi-disciplinary projects.
Part of the goal of the reorganization is to provide for better technical and administrative support for scientific reviewers, she added, noting the need for more structured data to help reviewers, in addition to more general support from a logistics point of view.
But Woodcock also warned that all of these changes and reorganizations are part of a proposal that has to go through a process of sign-offs on multiple levels, “so it’s unclear when we’ll achieve this, but not in the next six months.”
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email firstname.lastname@example.org for more information.
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