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The President’s Cancer Panel highlighted the sharp increase in U.S. cancer drug prices in a 70-page report to President Trump, calling for more value-based pricing, more competition in the drug market and “meaningful communication” about treatment options. Read More
The FDA announced plans for additional research into the impact of drug promotion on consumers’ understanding of prescription drug risks and benefits, and said a more targeted presentation of risks may help consumers retain key information. Read More
A Gastrointestinal Drugs Advisory Committee panel voted unanimously in favor of including a 16-week induction dosing regimen of 10mg Xeljanz (tofacitinib) twice daily in patients who have not reached “adequate therapeutic benefit” by Week 8 on the product label. Read More
The process of selecting clinical trial sites and launching studies, beginning with site identification and ending with study start-up completion, takes an average of 31.4 weeks, a full month longer than the average 10 years ago, according to new research from the Tufts Center for the Study of Drug Development. Read More
More states have aligned their oversight of drug compounding with federal standards in the last two years even though some states dropped inspections, according to an analysis by the Pew Charitable Trusts. Read More
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radiological and nuclear threats — must not be previously approved for another indication, the agency said, in a new draft guidance.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