Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
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 ...
Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...
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 ...
The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
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 ...
Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...