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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
Broadening clinical trials eligibility criteria will require re-assessing approaches and a change in culture, according to a panel of FDA representatives, government scientists, academic researchers and members of the pharmaceutical industry. Read More
The European Medicines Agency made several changes to a March 2016 guidance explaining the agency’s policy for publishing sponsors’ clinical trials data, including factors that could lead to rejection. Read More
Fifteen FDA officials, including Commissioner Robert Califf, called for broader uses of research methodologies, such as intervention and randomization, in real-world settings outside the typical venues of clinical trials. Read More
The FDA issued a draft guidance urging sponsors to work to control error rates before launching clinical trials with multiple endpoints, and provided several examples of appropriate statistical methods. Read More