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# Woodcock Unveils Proposed Overhaul of CDER Drug Review
- URL: https://www.fdaweb.com/woodcock-unveils-proposed-overhaul-of-cder-drug-review/
- Published: 2018-06-04T12:00:00.000Z
- Updated: 2026-09-15T00:10:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141590

CDER director **Janet Woodcock** has proposed changes to her Center’s new drug regulatory program that are intended to free up resources so staff can “focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities.” Proposals include regulatory and review process changes, organizational restructuring and improved information technology (IT), she said in a [just-posted notice](https://blogs.fda.gov/fdavoice/index.php/2018/06/fda-proposes-process-modernization-to-support-new-drug-development/?ref=fdaweb.com).  

Under the reorganization, the Center would see an increase in the number of offices that oversee the review divisions from five to nine. Within those offices, Woodcock said up to 30 review divisions would be established – up from the current 19.

Woodcock said the reorganization would enhance the Center’s focus on multidisciplinary teams in the drug review process. **“**A central component of our proposed changes involves stronger integration of our talented staff so they can better work together – within and across offices, a concept we refer to as ‘integrated assessment,’” she wrote. “Previously, CDER reviewers would seek consults from specialists in other scientific disciplines (as issues were identified in the course of review). For greater collaboration, a cross-disciplinary team will be assigned to work on a new drug application at the outset.”

To improve CDER’s knowledge management, Woodcock said her proposal would improve IT capabilities and access to information “to better enable the storage and management of the collected experience of our scientific review staff. Accurate historic information from many past drug reviews is essential to informing current and future reviews – and to assure consistent regulatory decision-making. We want to make it easy for staff to find and use scientific and regulatory data, information and precedents.”

Another key component in the reorganization is emphasizing the importance of safety across a drug’s lifecycle. “We will work to establish a unified post-market safety surveillance framework to monitor the benefits and risks of drugs across their lifecycles, both before and after approval,” she said.

Woodock hinted that the reorganization is in the early stages and there are “many steps to go before we can realize these changes.”