FDA Guidance Document: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
This post was written by Paul Sheives.
The FDA has issued a guidance document seeking to encourage the creation of contingency production plans for the manufacture of medically-necessary drug products and their components during emergencies that result in high absenteeism at production facilities. Medically-necessary products are those used to treat or prevent a serious disease or medical condition for which there is no other adequately available drug product that is judged by medical staff to be an appropriate substitute.
