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The FDA published guidance assisting sponsors in evaluating the effects of psychoactive drugs on the ability to operate a motor vehicle, saying reducing the incidence of accidents is a public health priority. Read More
Most life sciences companies plan to significantly step up their use of real-world data sources over the next three years, according to a new survey by the Tufts Center for the Study of Drug Development. Read More
The FDA finalized its guidance on developing direct-acting antivirals for chronic hepatitis C, outlining Phase III trial design options, enrollment criteria and safety evaluations for specific patient populations. Read More
The European Medicines Agency revised its 2009 guideline on developing treatments for axial spondyloarthritis, accounting for changes in clinical practice. Read More
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in previously untreated patients. Read More
The European Medicines Agency published a new draft guideline on developing medicines and vaccines against respiratory syncytial virus infections, including monoclonal antibodies and direct-acting antivirals. Read More
The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement. Read More