Will COVID Finally Help US FDA And Sponsors Overcome Their ‘Angst’ On Innovative Trial Designs?
The ‘sea change’ inside White Oak should be seen as very encouraging for sponsors, FDA official says.
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The European Medicines Agency has issued advice on managing thrombosis with thrombocytopenia syndrome (TTS) in people vaccinated with adenovirus vaccines, and Brazil has OKd the import of Sputnik V and Covaxin, albeit with numerous strings attached.
Agency seeking comment on document intended to replace the just-issued guidance on COVID-19 treatment development as FDA stresses the value of master protocols for developing clinical knowledge.
Sanofi R&D head John Reed says company has kept 95% of patients on its nearly 400 clinical trials and started 59 studies. Company has also stepped up collaborations and closed acquisitions, integrating employees remotely.