Paclitaxel Drug Products; Environmental Information Needed in New Drug Applications, Abbreviated New Drug Applications, and Investigational New Drug Applications

摘要

The Food and Drug Administration (FDA) is issuing this document to clarify the environmental information that must be submitted to the Center for Drug Evaluation and Research (CDER) for drug products containing paclitaxel. Paclitaxel is an active moiety that may be obtained or derived from various wild or cultivated species of yews. Under the National Environmental Policy Act (NEPA), all Federal agencies are required to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed of environmental analyses. This action is being taken to ensure that environmental factors regarding paclitaxel drug products are adequately assessed.