Seeking Stronger Antibiotic Warnings, Public Citizen Sues FDA
Executive Summary
The success of a Public Citizen lawsuit may hinge on whether the advocacy group can convince a judge that 16 months is an "unreasonable delay" in acting on a petition requesting labeling changes
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Agency chief counsel says continued priority-setting through lawsuits eventually may affect public health, while professor says FDA discretion not to act is at stake in some cases.
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Agency chief counsel says continued priority-setting through lawsuits eventually may affect public health, while professor says FDA discretion not to act is at stake in some cases.