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5 FDA approval decisions to watch in the 4th quarter

September 29, 2020


The next three months will be among the most consequential in the Food and Drug Administration’s modern history.

This fall, at least two of the leading coronavirus vaccine makers could seek emergency approvals, setting up what will be a series of momentous decisions for the regulator. The FDA will face immense pressure to clear a vaccine, but will be forced to make a call with significantly less information than usual to go on, due to the extraordinary speed at which developers have proceeded.

Should the agency authorize an experimental vaccine for emergency use, or grant a full approval, tens of millions of people will likely receive a shot, even under a controlled roll-out to high-risk groups.

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