Research and Development

FDA Plans More Research Into Drug Advertising

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

FDA Advisory Panel Recommends 10mg Xeljanz Dosing Regimen

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

FDA Issues New Guidance on Priority Review Vouchers

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radiological and nuclear threats — must not be previously approved for another indication, the agency said, in a new draft guidance.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