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

 
• By Brenda Sandburg

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 to determine whether to further expand its availability and suggested the FDA would be making a decision soon

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• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

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EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

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