WAYNE, PA — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational freeze-dried plasma (FDP) candidate.
The investigational FDP is a lyophilized (freeze-dried) unit of human plasma being developed under a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Materiel Development Activity (USAMMDA).
The investigational FDP is subject to the amendments made to section 564 of the Federal Food, Drug, and Cosmetic Act under H.R 4374 [Public Law No: 115-92]. This law allows for authorization of additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war.1
“This is an exciting milestone for Teleflex. We look forward to working with the FDA in a timely and efficient manner to address any needs for additional information that may arise,” said Liam Kelly, Chairman, President and Chief Executive Officer of Teleflex.
Teleflex’s freeze-dried plasma candidate is an investigational new drug and has not yet been approved by the FDA.
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