A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...
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 ...
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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 that there exists multiple bottlenecks that have caused the U.S. to lag behind ...
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 FDA’s drug review process can often be "unpredictable," and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.
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% ...
Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of ...
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 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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