AstraZeneca weighs seeking full, not emergency, US approval for Covid-19 shot, reports WSJ | Malay Mail

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NEW YORK, May 8 — AstraZeneca Plc may skip asking the US Food and Drug Administration for emergency-use authorisation for its Covid-19 vaccine and instead pursue the more time-intensive application for a full-fledged license to sell the shot, the Wall Street Journal (WSJ) reported yesterday....

Saturday, 08 May 2021 12:26 PM MYT

“It is important to note the substantial size of the file — in addition to the US trial data, the filing will also include analyses and pharmacovigilance from all studies to-date, in addition to real-world evidence data,” the company added.

 

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