PDUFA VII Talks To Begin With COVID-19, Other Familiar Issues To Consider
US FDA staffing problems and patient engagement enhancements will be listed as priorities during reauthorization kick-off meeting.
You may also be interested in...
Agency wants to use pandemic-interrupted clinical trials to gauge how decentralized approaches impacted study integrity and to inform prospective use of such designs post-COVID.
Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.
Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.