02/01/2021
https://www.congress.gov...
"But I think that what that piece really shows is we need to test. We need to determine what essential information the patient needs."
"I do hope you maintain a focus on actually having a paper pamphlet because for rural areas----"
"So we want to have you consider--heavy consideration--our concern."
"If the professional labels are not accurate and up-to-date, why would the FDA propose using those labels as the foundation for the patient medication information?"