An FDA advisory committee is scheduled 4/6 to discuss what is the optimal strain composition for Covid-19 vaccines to address emerging variants. According to a just-posted briefing document, the panel will also discuss when and how frequently to consider strain composition changes, and what is the optimal timing for a Covid vaccine booster dose among the general population and among specific sub-populations.

An independent review of FDA’s user fee program for biosimilars found that first-cycle approval rates were higher (67%, 14 of 21) during the first four years of the current five-year program than during the program’s 2013-2017 baseline first five years (39%, 9 of 23). The assessment said that “based on the quantitative data, observations, and feedback from interviews, it is reasonable to conclude that the BsUFA II Program has created conditions that enhance the ability of applicants and FDA reviewers to work toward application approval in the first review cycle.”