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.

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.

Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.

Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?

After decades of work, the US FDA released proposed requirements for a simplified version of the Medication Guide for all products. Electronic distribution in lieu of paper ‘upon a patient’s request’ would be allowed. Comments sought on the value of consumer testing of the documents.

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.