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. Source: International Pharmaceutical Regulatory Monitor

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 —…

The FDA proposed a new tactic in its fight against the opioid epidemic — blister packs of smaller quantities of opioid drugs that could give providers better prescription options, especially…

Drug sponsors seeking Qualified Infectious Disease Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA. Source: International Pharmaceutical Regulatory…

An Australian Therapeutic Goods Administration proposal to expand the information offered in its current naming system for biologics drew support from most respondents, with Mylan warning an alternate proposal to…

FDA Commissioner Scott Gottlieb spoke about the regulatory challenges of precision medicines and the agency’s plans to focus on durability and safety issues, in a panel discussion at the World…

Drug sponsors can prove the effectiveness of combination drugs for treatment of hypertension with trials that test the highest approved dosage rather than trials with multiple doses, the FDA said…