Food and Drug Administration Commissioner Scott Gottlieb, M.D., yesterday shared an update on the agency’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities. Among other actions, Gottlieb said FDA is “evaluating our current authorities to see what more we can do to better mitigate and prevent shortages, including receiving additional, key information from industry when they notify the agency about a possible shortage and identifying all establishments where manufacturing is performed associated with listed drugs and the type of operation performed at each such establishment.” In addition, Gottlieb said the agency could ask Congress to expand its authority to require manufacturers to conduct risk assessments “to identify the vulnerabilities in their drug supply, including vulnerabilities that could cause a shortage, and establish risk mitigation plans to address those risks.”
 

Related News Articles

Headline
The Food and Drug Administration yesterday released revised draft guidance for facilities that compound human drugs as outsourcing facilities.
Headline
The AHA, American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists, and Institute for Safe…
Headline
The Food and Drug Administration yesterday warned the health care community about complications that arise when pairing pain medications with intrathecal…
Headline
Oct. 27 is National Prescription Drug Take Back Day, an opportunity for the public to safely dispose of unwanted or expired prescription pills at sites…
Headline
The Food and Drug Administration yesterday released a series of guidance documents intended to help manufacturers develop generic transdermal and topical…
Headline
The National Academies of Sciences, Engineering and Medicine has released a report summarizing its Sept. 5-6 workshop on medical drug shortages during…