FDA Stalwart Pazdur Named Tidmarsh’s Substitute as CDER Director

After 26 years in ascending most cancers management roles on the FDA, Richard Pazdur will take the helm because the company’s chief drug regulator.

Pazdur, presently director of the FDA’s Oncology Heart of Excellence, was appointed as director of the Heart for Drug Analysis and Analysis, based on an announcement by the Division of Well being and Human Companies late Tuesday afternoon.

“Dr. Pazdur is a real regulatory innovator who will assist information our broader agenda to modernize the company and streamline the approval course of,” FDA Commissioner Marty Makary stated in an announcement accompanying the information launch.

“I’m honored to guide CDER at a time when the FDA is attaining long-sought regulatory reforms,” Pazdur stated in the identical launch. “I sit up for working intently with Dr. Makary and the medical specialists he’s assembled to assist our nation attain its peak in drug growth.”

The announcement comes lower than two weeks after former CDER director George Tidmarsh was ousted from the function amid a probe into his “private conduct” on the company. Tidmarsh was positioned on administrative depart days earlier than. Tidmarsh appeared to have second ideas about his choice to resign, nonetheless, conveying remarks to a gathering of senior staffers on the FDA’s Workplace of New Medication that he was not resigning.

Pazdur’s appointment additionally comes lower than per week after stories circulated that the longtime administrator had turned down the submit. Deputy CDER Director Mike Davis met with Pazdur and FDA Commissioner Marty Makary on November 3, based on The Pink Sheet, which first reported that Pazdur declined the function, however it’s not clear what they spoke about.

Pazdur first got here to the FDA in 1999 to guide the company’s Division of Oncology Drug Merchandise and later turned the founding director of the Oncology Heart of Excellence when it was established in 2017. He’ll proceed to additionally serve on this function till a successor is discovered, HHS stated Tuesday.