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The FDA will issue grants of $1 million each to Duke University and the Institute for Advanced Clinical Trials for Children to promote pediatric clinical trials and trial-related research. Read More
Clinical trial sponsors are doing a better job of representing women in drug trials but still lag in representing racial minorities, according to FDA research. Read More
Apple plans to launch a massive clinical trial for the Apple Watch’s ability to detect a heart condition that kills 130,000 individuals every year. Read More
For more efficient development of treatments for pediatric rare diseases, sponsors can implement controlled, multi-arm, multi-company clinical trials, according to a new draft guidance that the FDA says could help eliminate the need for certain studies. Read More
Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug Development. Read More
An Alzheimer’s research group offers positive news on clinical trials for Alzheimer’s drugs as well as suggestions for the way forward, in a new report. Read More
The FDA warned investigational medical device sponsor UVLrx Therapeutics for failing to obtain required authorization from its Institutional Review Board. Read More
In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. 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 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