Rafa Laboratories, Ltd.
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Latest From Rafa Laboratories, Ltd.
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Thinking Post-COVID: How Will US FDA Transition Drug, Vaccine EUAs To Full Approvals?
Sponsors seek clarity about the transition process, which could last a year or longer.
Remdesivir EUA Includes Promotional Limitations Absent From Chloroquine Authorization
Printed materials and promotions must describe Gilead’s drug as authorized, not approved, for treating COVID-19; although similar boilerplate restrictions are part of most of the EUAs issued for diagnostics and equipment to combat the novel coronavirus, they were not included in the authorization for chloroquine/hydroxychloroquine. Remdesivir's new website strongly resembles an approved brand product site.
As Chloroquine Demand Surges, Bayer Looks To Emergency Use Authorization To Enter US Market
Unlike diagnostics, EUAs for drugs are rare and the fact that there already are FDA-approved competitors for Bayer’s chloroquine phosphate product may make the decision more complicated.
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