Fate Of COVID-19 Convalescent Plasma Clinical Trials At Stake As US FDA Weighs EUA

 
• By Brenda Sandburg
  
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Clinical trials would have to move outside US if agency issues emergency use authorization for convalescent plasma, NYU prof says; experts disagree on whether the FDA should issue EUA.

Blood Plasma for treatments Coronavirus(Covid-19) Patients concept.Doctor is being Sought Blood Plasma from Recovered Covid-19 Patients.Research to the Coronavirus Disease 2019 Infection Treatments.
FDA may soon grant emergency use authoriztion for COVID-19 convalescent plasma • Source: Shutterstock

Despite opposition from top officials at the National Institutes of Health, the US Food and Drug Administration may go forward with issuing an emergency use authorization for COVID-19 convalescent plasma. The situation shows the difficulties the agency faces in ensuring patients have access to potentially beneficial therapies while avoiding policies that could undermine clinical trials.

FDA Commissioner Stephen Hahn noted in June that the agency was reviewing safety and efficacy data for COVID-19 convalescent plasma...

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