Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...
A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...
FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.
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 ...
Pharmaceutical Technology on MSN
FDA’s commissioner vouchers prompt questions about award process
Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...
Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of ...
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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