Drugs

Oncology Guru Pazdur Named New CDER Director

FDA has appointed longtime oncology regulator Richard Pazdur as the new CDER director, replacing George Tidmarsh after he stepped down earlier this month amid an internal ethics investigation and a defamation lawsuit tied to a public post criticizing a company’s drug (see story). Tidmarsh’s abrupt exit came just four months after his appointment to lead the agency’s drug center.

Pazdur, a 26-year FDA veteran, is the founding director of the Oncology Center of Excellence (OCE) and has played a central role in shaping the agency’s modern approach to cancer drug regulation. He will continue leading the OCE until a successor is named, according to an HHS release.

Over two decades, Pazdur has become known for building integrated, cross-center review models and for advancing policies that sped the development and approval of novel cancer therapies. Among his signature efforts are Project Orbis, which enables coordinated review of oncology drugs among international regulators; Project Facilitate, a program to help clinicians secure expanded access to investigational cancer treatments; and Project Renewal, an initiative to update outdated labeling for older oncology drugs.

FDA commissioner Marty Makary called Pazdur “a true regulatory innovator” who will help advance the agency’s push to modernize and streamline drug approvals. “He has a track record of success and is an impressive forward-thinking scientist,” he said.

Pazdur said he was “honored” to take on the CDER role as the agency pursues “long-sought regulatory reforms,” adding that he looks forward to working with Makary and his leadership team “to help our country reach its peak in drug development.”

Before joining the agency, Pazdur was a professor of medicine at The University of Texas M.D. Anderson Cancer Center. He earned his medical degree from Loyola University Chicago’s Stritch School of Medicine and completed training at Rush-Presbyterian St. Luke’s Medical Center and the University of Chicago. He has authored more than 800 scientific publications and two oncology textbooks.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome