We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued a draft guidance urging sponsors to work to control error rates before launching clinical trials with multiple endpoints, and provided several examples of appropriate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
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
The use of risk-based monitoring in clinical trials is expected to climb — with many sponsors planning to implement policies for the first time over the next two years — driven by the need to reduce oversight costs and mitigate risks. Read More
The EMA published a third revision to its guideline for human normal immunoglobulin for intravenous use, covering biological data, pharmacokinetics, clinical trials and patient follow-up, as well as changes in the manufacturing process of previously authorized products. 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
China’s Food and Drug Administration recently proposed revisions to its good clinical practices guidelines, standardizing the conduct of drug studies. According to the global law firm Ropes & Gray, the revisions are similar to those proposed by the International Conference on Harmonization guidelines. 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
When instituting electronic informed consent processes, sponsors should present study information in an easily understandable manner and ensure that documentation is legally effective, according to guidance from the FDA and the HHS Office of Human Research Protections. Read More