Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products." The draft guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop contingency production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the draft guidance is to provide to industry considerations for developing such emergency plans, as well as to discuss the Center for Drug Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies.