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Latest From Sue Sutter
Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.
Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.
Agency’s briefing document for 15 January review of the fixed-dose product combining an opioid and nonsteroidal anti-inflammatory reflects application of opioid benefit/risk framework described in June draft guidance.
Sponsors should notify US FDA quickly when they detect data quality issues in preclinical and clinical research, particularly for applications under review, experts say in a rebuke to Novartis’ delayed notification about Zolgensma data manipulation.
Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.
Agency issued final classification determinations within 90 days after an inspection 86% of the time in fiscal year 2019 and continues to reduce the time interval for sending GMP warning letters, CDER compliance director Donald Ashley tells FDLI conference.