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The National Institutes of Health published a summary of the 240 comments received on a rule mandating that researchers post the results of their clinical trials on a public website. Read More
To achieve the national cancer moonshot’s goal of accelerating cancer research, the FDA is planning to encourage more seamless, adaptive clinical trial designs for oncologic drugs. Read More
Drug sponsors that have falsified data will face three years of probation before being allowed to refile marketing applications, the Chinese FDA says. Read More
Juno Therapeutics has been sued in a class-action lawsuit alleging that the company violated federal securities law by failing to disclose a death during a clinical trial. Read More
Plasma fibrinogen can be used as a biomarker in interventional clinical trials examining patients at high risk for exacerbations or all-cause mortality in chronic obstructive pulmonary disease, according to final guidance to industry issued by FDA. Read More