Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...
Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to ...
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 ...
In response to Marty Makary warning the US may lose the early‑stage drug development lead to China, Brian Scanlan says speed, ...
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 ...
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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 ...
In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...
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% ...
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