COVID Vaccine Postmarket Monitoring Will Depend On Which Adverse Events US FDA Wants To Watch
US FDA has the unenviable task of picking the most important adverse events to track once coronavirus vaccinations begin; CDC's list will need to be winnowed to 10-20 to make the surveillance feasible, and which AEs make the cut may be informed by the vaccine trials, as well as clinical experience with COVID infections.
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Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.
US FDA will be cautious about development of a COVID-19 vaccine for children, Commissioner Hahn says at the Financial Times US Pharma And Biotech Summit.
Investigators should plan to find the vital status of discontinued patients, guidances states. Participants need frequent reminders to complete PRO instruments, agency recommends.