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Several large drugmakers and industry groups commented on FDA’s proposal to require higher quality management standards for nonclinical studies used to support product applications. Read More
The FDA compiled 22 case studies of different drugs, vaccines and devices that demonstrated promising results in Phase II studies, but later failed in larger Phase III clinical trials. Read More
Fifteen FDA officials, including Commissioner Robert Califf, called for the broader uses of research methodologies in real-world settings, but cautioned against expectations for “quick wins” in efficiency and savings. Read More
The European Medicines Agency made several changes to a guidance explaining the agency’s policy for publishing clinical trials data and factors that could lead to rejection. Read More
CBER released a set of guidance topics that the center is considering for development this year, covering blood and blood components, tissues and advanced therapies, and chemistry, manufacturing and controls changes. Read More
HHS backed down from implementing its more controversial provisions in a broad overhaul of its Common Rule, including requiring researchers to obtain written consent before testing a donor’s biospecimens, even if the samples were presented with no personally identifying information. Read More
The FDA updated its guidance for botanical drug development to include recommendations for navigating combination drug regulations, with possible criteria for receiving a waiver. Read More
An FDA advisory committee recommended clinical trial endpoints for evaluating treatments of men with hypogonadism while maintaining or improving testicular function. Read More
Officials from the FDA and the National Institutes of Health, in cooperation with public, private and industry stakeholders, published a framework for defining the levels of evidence needed to support the regulatory qualification of biomarkers for drug development. Read More