Tag: emergency use authorization

The Disasters That Built the FDA and Where We Go From Here

Transparency, integrity, and rigorous evaluation of drug safety and efficacy are the bedrock of the FDA. Diverging from these tried-and-true principles, such as by issuing an emergency use authorization for a Covid-19 vaccine candidate without clear emerging evidence of its benefits outweighing its risks, would jeopardize both the public health and the public’s trust in the agency. 

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The FDA Needs to Get Back to Basics

According to federal law, the FDA may approve emergency use authorizations on the condition that data on the safety and effectiveness of authorized medications will be collected and analyzed. To protect patients from unsafe drugs and ensure the effectiveness of treatments, the FDA needs to routinely exercise that power.

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