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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Sponsors seek clarity about the transition process, which could last a year or longer.
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.
FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments
Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs.