New Opioids May Need Comparative Effectiveness Data For Approval
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.
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As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.
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