The FDA is providing additional information on trial designs for sponsors developing therapies to treat allergic and nonallergic rhinitis. Read More

CBER’s Allergenic Products Advisory Committee gave a less than stellar assessment on the outlook of clinical trials for immunotherapies to treat food allergies. Read More

The FDA plans to push for greater diversity in clinical trials, says Robert Califf, the presidential nominee to head the agency. Read More

The European Medicines Agency is asking for feedback on a revised guideline for the treatment of Alzheimer’s disease and other types of dementia. Read More

With the clinical trials industry facing its lowest rates of recruitment and retention, drug developers must incorporate big data and patient voices to improve trial efficiency and hasten innovation, says a new report by the Tufts Center for the Study of Drug Development. Read More

CBER’s Allergenic Products Advisory Committee gave a less than stellar assessment on the outlook of clinical trials for immunotherapies to treat food allergies. Read More

Over the past decade, the number of privately funded clinical trials has nearly doubled, while the number of government-sponsored studies have fallen, according to a new report from Johns Hopkins University. Read More

Over the past decade, the number of privately funded clinical trials has nearly doubled, while the number of government-sponsored studies have fallen, according to a new report from Johns Hopkins University. Read More

Underscoring the importance of pediatric trial design, cancer experts recently guided drugmakers on whether their research plans for two investigational drugs could be feasibly used to combat some of the most life-threatening and hard-to-treat childhood cancers. Read More

The FDA is calling for risk management plans for clinical development of microbial vectors for gene therapy, focusing on the potential for vectors to germinate, regerminate or reseed. Read More