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Regulatory Focus™ > News Articles > 2020 > 1 > OND Reorganization Slightly Delayed as Woodcock Outlines 2020 Priorities

OND Reorganization Slightly Delayed as Woodcock Outlines 2020 Priorities

Posted 13 January 2020 | By Zachary Brennan 

OND Reorganization Slightly Delayed as Woodcock Outlines 2020 Priorities

Peter Stein, director of the Office of New Drugs (OND) at the US Food and Drug Administration (FDA), told sponsors on Monday that the restructuring of OND this month will be delayed by about a week.

“We initially anticipated launching Phase III on January 13, 2020, which would formally stand up the Office of Nonprescription Drugs, and the Office of Specialty Medicine, as well as the Regulatory Operations Divisions associated with these therapeutic areas. Due to a few minor delays in getting everything aligned for the transition, we will now launch this phase on January 21,” Stein said via email.

He also told sponsors that they would receive another communication regarding Phase III when it begins next week. “The final phase (Phase IV) is still on track.  Additional details on the final phase are forthcoming,” Stein added.

The changes will create offices for interrelated disease areas and divisions with clearer and more focused expertise, FDA said, noting the number of OND offices that oversee its review divisions will increase from six to eight, and there will be increases in the number of OND clinical divisions from 19 divisions to 27, plus six non-clinical review divisions.

2020 Priorities

Meanwhile, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), sent an email to staff on Monday explaining the strategic goals for several topics that cross multiple CDER offices.

On the OND modernization, Woodcock noted that FDA is looking to fully implement a new review process and template for integrated reviews of new drug applications and biologics license applications.

“Other aspects of modernization include implementing standardized and consistent approaches for managing IND applications and post-market drug safety. Because of staff commitment to this multi-phase initiative, we are operationalizing a new organizational structure across the Office of New Drugs, the Office of Translational Sciences, the Office of Surveillance and Epidemiology, and the Office of Pharmaceutical Quality,” she wrote.

Woodcock also highlighted FDA’s risk-based approach to postmarket safety, noting that CDER assesses the nature of the drug, potential adverse events, the intended population, the potential for serious outcomes and the impact on individuals and public health. 

“We will enhance postmarket safety practices through increased coordination so that we can rapidly analyze and resolve drug safety problems when they arise. For example, we continue to investigate the presence of genotoxic impurities, called nitrosamines, found in some types of drugs,” she wrote.

In addition, she discussed the upcoming next round of user fee negotiations, which need to be reauthorized by 2022, as well as the creation of the Compounding Quality Center of Excellence to improve the quality of compounded medicines. And she touched on FDA’s work addressing the opioid crisis and drug shortages.

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