BioCytics is pleased to announce they successfully reached a regulatory milestone for de-risking clinical development plans with a productive FDA INTERACT meeting during which they discussed ...
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, ...
Peytant Solutions CEO John Schorgl explains how his device startup turned a complex FDA de novo application into a lasting ...
The US Food and Drug Administration (FDA) has appointed one of its most respected cancer drug regulators to lead the agency’s main division for approving new drugs.
A new report alleges that FDA Commissioner Marty Makary is facing criticism over his management style amid high-level ...
The FDA on Nov. 11 appointed Richard Pazdur, MD, as the new director of the Center for Drug Evaluation and Research.Pazdur ...
The U.S. Food and Drug Administration can approve new personalized treatments for rare and deadly genetic diseases based on ...
A sponsor will have to demonstrate success with "with several consecutive patients with different bespoke therapies" to ...
The Food and Drug Administration has appointed Richard Pazdur, the founding director of the agency’s Oncology Center of ...
Pharma Pulse: FDA Appoints Richard Pazdur as CDER Director Amid 340B Tensions and Novartis Expansion
This episode of Pharma Pulse discusses how Dr. Richard Pazdur’s appointment signals a new era for FDA drug evaluation, why hospitals are opposing the government’s 340B pilot program, and how Novartis ...
The “plausible mechanism” pathway, outlined by Martin Makary and Vinay Prasad, is designed to help accelerate treatments ...
In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory ...
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