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The FDA plans to launch a new pilot program to improve the efficiency of orphan designation submissions and reviews, Commissioner Scott Gottlieb announced Monday. Read More
The European Medicines Agency published a reflection paper on assessing the frailty of elderly patients in clinical trials, recommending the Short Physical Performance Battery assessment for its prognostic value and ease of use. Read More
The FDA updated its guidance to institutional review boards and clinical investigators, detailing its views on reimbursements for lodging and travel for clinical trial participants. Read More
Drug products seeking an FDA designation as a medical countermeasure — defined as products used to diagnose, prevent or treat conditions associated with chemical, biological, radiological and nuclear threats — must not be previously approved for another indication, the agency said, in a new draft guidance. Read More
The federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to take effect Jan. 19 — and warned the public to expect additional delays down the line. Read More
The final guidance on DMD and related dystrophinopathies said endpoints that measure change of function in a wide range of deficits may offer advantages. Read More
The FDA released five guidances on treatments for a variety of neurological disorders including Duchenne muscular dystrophy and Alzheimer’s disease, offering suggestions for trial designs and methods of measuring effectiveness. Read More
Nearly 14 percent of all drugs in clinical trials eventually win approval from the FDA — a much higher percentage than previously thought, according to a new study from the MIT Sloan School of Management. Read More
Few developers of antibiotics for high-priority pathogens have a plan in place to ensure access when development is complete, researchers found. Read More
The FDA updated its guidance to institutional review boards and clinical investigators, detailing its views on reimbursements for lodging and travel for clinical trial participants. Read More
Drugmakers must do more to ensure access to treatments for antimicrobial-resistant superbugs, but GlaxoSmithKline and Johnson & Johnson are doing more than other organizations on 16 metrics of progress, according to the Access to Medicines Foundation, a Netherlands-based non-profit. Read More