FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates.
On Jan. 16, 2018, FDA published another update on the drug shortages that are occurring because of the impact of Hurricane Maria on Puerto Rico. The agency states the shortages of IV fluids should continue to improve and the agency is working with manufacturers to ensure facilities are operating at full capacity. FDA warns, however, that it might take some time for efforts to be felt in the marketplace.
Potential import sites for both small and larger volume IV saline bags are also being looked into by the agency. FDA also expects to approve product from additional companies in the next several weeks. Additionally, the agency is asking companies to submit data to extend expiration dates, if safe. This would allow product nearing expiry to be used by hospitals.
FDA is continuing to monitor the situation and the impact of mitigation strategies. According to the agency, some institutions have a very limited supply of IV fluids on hand. “We believe that as more supply enters the market, these challenges will start to diminish,” Commissioner Scott Gottlieb, MD, said in a statement.
The agency is looking at how hospitals may be using empty IV containers as an alternative to filled bags. These containers are regulated by FDA as class II medical devices. “We understand that, with the shortage of filled bags, hospitals and other healthcare providers are turning to the repackaging or compounding of IV saline fluids and utilizing empty IV containers. This is resulting in diminished supplies of these containers and concerns that supplies of empty bags could tighten further,” Gottlieb stated.
The demand caused by the flu may have further impact on the shortage, according to Gottlieb. The agency is encouraging healthcare organizations and hospitals to contact FDA directly if they experience a shortage in supply. Hospitals should also consider recommendations issued by the American Society of Health-System Pharmacists (ASHP) and the University of Utah, as well as the Small-Volume Parenteral Solutions Shortage guidance.
Source: FDA
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.