"We [FDA] have determined that [normal reporting] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis... Therefore we have determined you are required to conduct the following studies... [lists several studies due 2024 and 2025]." (pg 6-8)
They then also list the pregnancy study at bottom of page 9.
Thank you!!!
"We [FDA] have determined that [normal reporting] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis... Therefore we have determined you are required to conduct the following studies... [lists several studies due 2024 and 2025]." (pg 6-8)
They then also list the pregnancy study at bottom of page 9.
Welcome.