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

摘要

The guidance provides considerations for the development and implementation of a plan for production of MNPs during a crisis, including specific elements that should be included in the plan. The guidance also discusses the Center for Drug Evaluation and Research's (CDER's) intended approach to helping to avoid drug product shortages that could have a negative impact on the national public health during such emergencies. The guidance is intended for manufacturers of drug and therapeutic biological products regulated by CDER and manufacturers of raw materials and components used in those products. FDA strongly recommends that drug product manufacturers show this guidance to all suppliers and contractors associated with the manufacture of MNPs and discuss the guidance with them to stimulate planning to avoid or mitigate disruptions in supply.