CDER Rejects Petition for a Temporary Hold on Opioid NDAs

The FDA has denied a petition from Public Citizen seeking a temporary ban on approvals of new drug applications for opioids until the agency creates a review process to assess their risks and benefits.

The advocacy group petitioned CDER in April calling for a ban until the agency creates a regulatory framework specifically for approving new opioid products or formulations.

Public Citizen called for the framework to include recommendations from the National Academies of Sciences, Engineering, and Medicines on how to help mitigate the opioid epidemic.