Therapeutic Solutions International, Inc. has announced the preparation for filing an Emergency Use Authorization (EUA) to the FDA for JadiCells™ in treatment of COVID-19 associated lung injury. If you are a Physician or Hospital Administrator interested in obtaining JadiCells™ in treatment of COVID-19 lung failure under EUA, eIND, or Right to Try, please use the email contact for James Veltmeyer, M.D., Chief Medical Officer of the company at email@example.com.
The EUA is a mechanism that allows FDA to help strengthen the nation’s public health protections against threats such as infectious diseases by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. Under this provision, the FDA may authorize unapproved medical products to be used in an emergency to treat serious or life-threatening diseases or conditions.
Right-to-try laws are U.S. state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies that have completed Phase I testing but have not been approved by the Food and Drug Administration
A physician may decide to request use of an investigational antiviral product through a single-patient Emergency Investigational New Drug (EIND) application if:
- the physician considers the product may be urgently needed for the patient’s serious or life-threatening condition;
- no satisfactory alternative therapy is available; and
- the patient cannot receive the product through any existing clinical trials or expanded access protocols
TSOI one pager to give to your loved ones physician
Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial
FDA: Right to Try Fact Sheet – US Food and Drug Administration