Abuse-Deterrent Opioids Forcing FDA To Better Define 'Food'
Meaning of 'take with food' or 'take on an empty stomach' may not be self-evident, advisory committee members say.
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Elite's Opioid Carries Risk Of Overdose After Heavy Meal, FDA Says
Complete response letter explains that SequestOx labeling could not adequately mitigate the risk; firm to propose another bioequivalence study in patients receiving drug after eating fatty food.
AstraZeneca’s Nirsevimab: US FDA Wants Input On How It Would Fit With Pediatric RSV Vaccines
Proposed RSV prevention treatment for infants and neonates showed efficacy with few safety concerns, but with pediatric vaccines in development, FDA wants the Antimicrobial Drugs Advisory Committee to discuss what data would be needed to determine appropriate use in vaccinated infants and mothers.
Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availability
CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.