> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Previews Reforms as Pazdur Takes Over CDER
- URL: https://www.fdaweb.com/fda-previews-reforms-as-pazdur-takes-over-cder/
- Published: 2025-11-14T12:00:00.000Z
- Updated: 2026-09-14T15:26:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160219

FDA commissioner **Marty Makary** and CBER director **Vinay Prasad** offered an unusually candid preview of upcoming agency reforms during an [*FDA Direct* podcast](https://www.fda.gov/media/189621/download?attachment&ref=fdaweb.com) focused on the appointment of longtime oncology regulator **Rick Pazdur** as CDER’s new director ([see earlier story](https://www.fdaweb.com/oncology-guru-pazdur-named-new-cder-director/)). The two officials described Pazdur — formerly head of the Oncology Center of Excellence (OCE) — as a career regulator and “true innovator” whose leadership is expected to drive major structural changes across the agency, especially in harmonizing regulatory expectations between CDER and CBER.

Prasad said he and Pazdur have been working “hand in glove” for the past five to six months to resolve longstanding inconsistencies between the centers. “For years the OCE was supposed to be the bridge between CDER and CBER, but there wasn’t always alignment,” Prasad said. “Different demands, different standards, and communication gaps. That’s all changed now.”

He described new organ-system–based working groups that bring together reviewers across centers to align endpoints, data expectations, and regulatory approaches. Makary acknowledged past internal tensions, joking that Prasad’s description of “not always great alignment” was “putting it mildly… We’re one organization, one FDA,” Makary said. “Leadership here requires impeccable teamwork, and Rick embodies that.” Pazdur is also pushing to expand the CDER–CBER alignment model beyond oncology, Prasad said, proposing new joint teams in cardiology, nephrology, and rare diseases.

Both officials emphasized that upcoming reforms are not about speeding reviews by increasing workload, but by eliminating delays between internal handoffs. “If reviewers finish in eight weeks but the process allows a year, you’re not accelerating anything,” Makary said. He described Pazdur’s push to reduce “idle time” in the system and shrink the backlog of stalled reviews. Prasad said Pazdur has also proposed new mechanisms to enable reviewers to give more timely feedback to sponsors and streamline multi-step internal reviews.

Both Makary and Prasad praised Pazdur’s role in advancing the use of surrogate endpoints and adaptive trial designs in oncology, saying similar innovations could be adopted agency-wide. Prasad emphasized that FDA already uses two types of surrogate-based approvals:

- **Accelerated approval** using surrogates “reasonably likely” to predict clinical benefit.
- **Traditional approval** using validated surrogates that reliably predict benefit.

He said CBER will soon issue traditional approvals based on surrogate endpoints that show unusually large and credible effects early in development. Makary highlighted Pazdur’s earlier reforms — Project Orbis, seamless trials, and confirmatory-trial-based pathways — as precedents for broader modernization.

The two leaders also previewed a major shift toward Bayesian reasoning, continuous statistical monitoring supported by artificial intelligence, and a totality-of-evidence framework that emphasizes credibility over rigid rules. Prasad said FDA must move beyond a checklist mindset. “It’s not about the number of trials. It’s about the quality of the evidence,” he said, citing effect size, endpoint validity, control-arm quality, pre-specification, biologic plausibility, and real-world confirmatory data as critical factors.

Makary suggested reconsidering the default expectation for two pivotal trials and exploring new statistical methods that better reflect differences between diseases and drug classes. He said FDA leaders are actively socializing reforms internally and hope to make announcements “in the coming months,” including:

- Revised expectations for real-world evidence in regulatory submissions
- Updated statistical frameworks, potentially incorporating Bayesian methodologies
- Continued steps to reduce reliance on animal testing
- Broader alignment efforts between CDER and CBER

“We want to innovate the regulatory process while keeping it impeccably independent,” Makary said. “Good stuff is happening across the board.”