FDA licenses first US freeze-dried plasma product
New CapabilitiesEzplaz stores at room temperature and reconstitutes in minutes, so plasma can reach combat zones and rural emergencies
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Overview
Updated 1 hour agoFor decades, US plasma transfusions required a freezer and time to thaw. Ezplaz, the first US-licensed freeze-dried plasma, reconstitutes in about 2.5 minutes and sits on a shelf for a year.
The shift moves plasma out of the hospital blood bank and into ambulances, combat zones, and disaster sites. The FDA granted the biologics license to Vascular Solutions, a Teleflex subsidiary, after a 12-year research partnership with the Defense Health Agency. The approval covers adults only, and only when frozen plasma is unavailable.
Why it matters
Bleeding patients in combat zones and rural areas can now receive plasma before reaching a hospital blood bank, buying minutes that can decide survival.
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People Involved
Organizations Involved
The FDA's Center for Biologics Evaluation and Research regulates blood products and issued the Ezplaz license.
Teleflex, based in Wayne, Pennsylvania, owns Vascular Solutions, the subsidiary that holds the Ezplaz license.
The Defense Health Agency manages medical care for US service members and ran the military side of the Ezplaz partnership.
One of the largest US blood suppliers, the Red Cross declared a national supply crisis weeks before the Ezplaz approval.
Timeline
April 2014 August 2026
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FDA licenses Ezplaz, first US freeze-dried plasma
Today RegulatoryFDA licenses Ezplaz, the first US freeze-dried plasma, for adults when other plasma is unavailable.
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Red Cross warns of national blood supply crisis
ContextRed Cross warns donations hit a four-year low; O-positive supply under one day.
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Congress authorizes military-FDA medical product collaboration
PolicyCongress authorizes military-FDA collaboration to speed products for service members.
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Vascular Solutions and military sign plasma research pact
PartnershipVascular Solutions and the Defense Health Agency sign a freeze-dried plasma research pact.
Historical Context
3 moments from history that rhyme with this story — and how they unfolded.
World War II dried plasma (1940s)
The US pioneered dried plasma in World War II, shipping large quantities to field hospitals to treat shock and hemorrhage. The process pooled plasma from many donors.
Hepatitis outbreaks traced to pooled plasma led the US military to abandon dried plasma after the war.
The US shifted to frozen single-donor plasma with viral screening, while some foreign militaries kept freeze-dried plasma in use.
Ezplaz brings back a technology the US invented and abandoned, this time with single-donor sourcing and modern testing.
Public Law 115-92 (2017)
Congress directed the Department of Defense and the FDA to collaborate on speeding up development and review of products for serious conditions facing service members. Freeze-dried plasma was among the first products identified under the law.
The FDA issued guidance in 2019 for manufacturers developing dried plasma products.
The law created a formal review track that carried Ezplaz from a 2014 research pact to a 2026 license.
It is the institutional mechanism behind this approval.
French military freeze-dried plasma (2000s-2026)
France's armed forces have used freeze-dried plasma for decades. US special operations forces carried French-made FDP for 15 years, importing it case by case under special access because no US-licensed product existed.
The imported product proved freeze-dried plasma works in the field but lacked a US regulatory license.
US reliance on imports left a supply gap the Defense Health Agency pushed to close with a domestic product.
Ezplaz replaces an import-dependent workaround with a US-licensed product, changing procurement and supply reliability.
