The FDA updated its nearly 15-year-old policy on performing environmental assessments and reviewing potential exclusions under the Office of Pharmaceutical Quality.
Federal law requires government agencies to assess the environmental impact of their actions. For the FDA, this extends to approvals of NDAs, ANDAs and BLAs, as well as other regulatory activities.
The FDA may refuse to file or receive any applications lacking an environmental assessment or a request to be excluded from the requirement. The agency last updated its Manual of Policies and Procedures on the topic in 2003.