MANILA, Philippines — The Food and Drug Administration (FDA) has canceled its inspection trip to Russia after the Gamaleya Research Institute submitted the required documents to secure an emergency use authorization (EUA) in the Philippines for its Sputnik V COVID-19 vaccine.
FDA Director-General Eric Domingo said a team from the drug regulator was supposed to fly to Russia this week to inspect the factory of Gamaleya Research Institute. Gamaleya earlier invited the FDA to visit its factory instead of submitting a Certificate of Good Manufacturing Practice, two months after applying for a EUA.
“The inspection trip to Russia did not push through because last Friday the applicant s…
Keep on reading: FDA cancels inspection trip to Russia as Gamaleya submits EUA documents