
FDA's Pazdur expresses concerns over the hindrance caused to other sponsors' applications due to fighting accelerated approval withdrawal. US accelerated approvals face criticism at AACR24. Congressional authorities struggle with drug companies over accelerated approval withdrawal, leading to FDA time constraints. FDA considers adding another myeloma endpoint for accelerated approvals, affecting timely access. FDA's Pazdur criticizes sponsor-driven Adcomm open public hearings, emphasizing the need for confidence in the system.
“I think that this has the potential of really providing a lack of confidence in the system if this continues,” FDA's Pazdur said. “I'm all for the public hearings,” Pazdur was quick to add. “I would like them to be what they were intended to be.” https://t.co/bBzgKBL1nn
Adcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur https://t.co/kVNe3sOnUx #PinkSheet
As FDA weighs another myeloma endpoint for accelerated approvals, experts say timely access is at stake https://t.co/p5TaMImO4f






