Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to ...
Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...
The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
In response to Marty Makary warning the US may lose the early‑stage drug development lead to China, Brian Scanlan says speed, ...
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FDA commissioner raises concerns about US pharma lagging behind China in drug development
Makary urged the Trump administration to partner with the pharmaceutical industry. ・The senior official is of the opinion ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Psychedelic drug development can still benefit from the FDA Commissioner’s National Priority Review Voucher Pilot Program, though the CNPV designation was not given to Compass Pathways’ synthetic ...
Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...
In his report, Senator Bill Cassidy suggested a slate of changes to the FDA to support broader drug access and to reduce ...
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