FDA unlikely to rule on Merck’s COVID pill before December

The Seattle Times

The Food and Drug Administration said Thursday it will ask its outside experts to meet in late November to scrutinize Merck’s pill to treat COVID-19.

The Nov. 30 meeting means U.S. regulators almost certainly won’t issue a decision on the drug until December, signaling that the agency will conduct a detailed review of the experimental treatment’s safety and effectiveness. The panelists are likely to vote on whether Merck’s drug should be approved, though the FDA is not required to follow their advice.

It marks the first time the FDA has convened its expert advisers before ruling on a coronavirus treatment. Advisory committee meetings have become a standard part of its process for reviewing vaccines.

The agency decided to convene the meeting to help inform its decision-making, its top drug regulator said in a statement.

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Thursday, October 14, 2021 - 12:17pm

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