CDER Priorities for 2019

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Recently, the U.S. Food and Drug Administration’s (FDA) director of the Center for Drug Evaluation and Research (CDER) described the center’s priorities for 2019. Opioids will be a top issue along with drug compounding. She also described more on the Office of New Drugs and implementing recent legislation.

Major Priorities

As Regulatory Focus wrote, Woodcock said there has been some reduction in the prescribing of opioids. But there are over 200 million prescriptions for opioids every year. “It’s really the general population exposure that we have to focus on,” she said. A second priority noted was implementing the legislative framework around drug compounding. FDA is working with the National Academies of Sciences, Engineering and Medicine, as well as the Kennedy Krieger Institute at Johns Hopkins University to deal with compounding.

The third top priority is the modernization of the Office of New Drugs (OND). “Over the next year, we’ll be implementing many things we’ve been talking about,” Woodcock said, including regulatory automation tools and a multidisciplinary review template to reduce redundancies. The modernization will also increase the number of offices within OND from five to nine and increase the number of review divisions within those offices from 19 to 30.

The fourth priority mentioned is on implementing provisions of the 21st Century Cures Act, which has been ongoing. The final priorities laid out by Woodcock were related to implementing the FDA Reauthorization Act and other user fee goals, in addition to tracking the implementation of Track and Trace legislation, which just recently came into effect.

In a follow up post to FDA’s website, she noted the importance of drug safety as a priority. Woodcock pointed to the agency’s annual report, Drug Safety Priorities 2018, which illustrates how CDER addresses drug safety. The report provides updates on FDA’s ongoing initiatives, discusses new work, and highlights last year’s safety-related milestones and achievements.


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