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.
You may also be interested in...
CGMP Requirements Apply To Remdesivir In COVID-19 Emergency – But Not To Chloroquine Or HCQ
Among the differences between the emergency use authorizations is that manufacturing quality requirements will apply to Gilead’s remdesivir, while chloroquine and hydroxychloroquine received blanket waivers as part of their EUA from the US FDA.
Woodcock Said To Have Guided Hydroxychloroquine EUA In ‘Brokered Compromise’ To Limit Use
In whistleblower complaint, Rick Bright claims FDA Commissioner Hahn advocated for distributing hydroxychloroquine to pharmacies across the US, a departure from the approved emergency use authorization. Bright's complaint paints CDER Director Woodcock in a favorable light, saying she helped avoid an expanded access IND protocol for the potential coronavirus treatment.
US FDA Safety Alert For Hydroxychloroquine Is Latest Turn In Drug's Strange Journey
As potentially life-threatening heart problems emerge in coronavirus patients, FDA says hydroxychloroquine should be taken only in clinical trial or hospital settings under the Emergency Use Authorization.