expanded access

(redirected from Expanded access protocol)

expanded access

Any of several methods used by the FDA to make experimental treatments available to patients who have failed conventional treatments and are not participating in formal clinical trials.
References in periodicals archive ?
Ten tab-cel-treated patients with EBV-associated diseases from a multicenter expanded access protocol study were selected.
ZMapp is currently being made available to EVD patients through an Expanded Access Protocol offered to sites in the United States, Guinea, Liberia, and Sierra Leone.
Previously available under an investigational new drug (IND) expanded access protocol, VariZIG, a purified immune globulin preparation made from human plasma containing high levels of anti--varicella-zoster virus antibodies (immunoglobulin G), is the only varicella zoster immune globulin preparation currently available in the United States.
An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Manitoba) was granted in February as supplies of the only licensed U.S.
An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Canada) was granted in February as supplies of the only licensed U.S.
An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Man.) was granted in February as supplies of the only licensed U.S.
The oral presentation summarized the evaluation of tab-cel in an analysis of EBV+ LMS patients from three clinical studies, 2 single-center, open-label studies and the multi-center expanded access protocol study.
Varicella zoster immune globulin (VZIG) anticipated short supply and alternate product availability under an investigational new drug application expanded access protocol. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration; 2006.
An expanded access protocol under the IND application enables use of investigational VariZIG for patients who meet the protocol's enrollment criteria ([dagger]) and who choose to participate.
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