The drug President Trump believes 'cured' his COVID-19 isn't approved for use for ordinary Americans and still must clear many regulatory hurdles before it is.
Fact check: Trump's antibody therapy not made from fetal stem cells but fetal-derived cells used during testing
That's different from the regular approval process, which requires that"the drug is determined to provide benefits that outweigh its known and potential risks," according to FDA. Regular drug approval requires FDA to review applications within 10 months. A priority review designation for drugs that offer"major advances in treatment or provide treatment where none existed" takes six months,An EUA is even faster than a priority review but has no set timetable, said FDA spokesperson Chanapa Tantibanchachai.
An EUA could come very quickly if the FDA feels Regeneron's data is solid or, some fear, due to influence from the White House., such as hydroxychloroquine. That drug was pushed strongly by Trump and was initially approved for emergency use, which was later revoked.called upon FDA to base any approvals on established scientific standards.
If Regeneron were to receive an EUA for its monoclonal antibody treatment, it would not mean the company could market it long-term.
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