Insights Into The FDA's Guidance On Managing Drug Supply

By Peter H. Calcott, Ph.D., president and CEO, Calcott Consulting LLC

In April 2023, the FDA issued an updated guidance superseding and replacing the previous 2020 document about managing drug shortages and explaining what was expected of industry and how the agency was going to manage the shortfalls. The spirit of the original document remains, although certain details are changed to add clarity and to reflect current thinking.