Senior Regulatory Review Officer USPHS Silver Spring, Maryland, United States
A brief discussion of the FDA's drug shortage program. The discussion will explain how the FDA works to identify, prevent and mitigate drug shortages. It will also speak to the requirements for the pharmaceutical industry to notify FDA of any situations that could lead to discontinuation or lack of availability for drug products. The presentation will explain what tools FDA has to meet these mitigation and prevention efforts. It will speak to what pharmacists and technicians can do to support his effort. Lastly, it will update some of the most recent efforts on COVID-19 related products as well as recent communications on guidance of industry.
Discuss what FDA can and cannot do to prevent and mitigate drug shortages.
Describe pharmaceutical industry's role in drug shortage prevention and mitigation.
Describe how to report a drug shortage to the FDA.
Explain where to gather information on product availability as well as agency efforts to post information on shortage mitigation efforts.