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Demers A, McNicoll N, Febbraio M, Servant M, Marleau S, Silverstein R, Ong H

1 FDA Commissioner Marty Makary, MD, MPH, characterized the agency's current posture as a fundamental shift in regulatory strategy

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Between January and March this year, 1,906 apparent opioid toxicity deaths were reported, according to the Public Health Agency of Canada

The stated reason was questions about bioanalytical method validation that had surfaced late in the review, questions that could affect interpretability of certain pivotal study data. In plain terms: the agency developed a concern about whether the assays used to measure the drug in the pivotal trials could be trusted, and it pulled the meeting rather than hold it