FDA Reports Citizen Petition Requirements Strain Resources

In a new report to Congress, the FDA reiterated the strain on agency resources required to respond to 505(q) citizen petitions requesting action on pending ANDAs, biosimilars or 505(b)(2) applications. The strain has been further exacerbated since the Food and Drug Administration Safety and Innovation Act shortened the FDA’s timeframe to respond to the petitions by 30 days, from 180 days to 150. The agency has had to direct resources away from other important initiatives to comply with the new, shorter deadline, the report states.
Washington Drug Letter