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 ?
Apr 20, 2015: SAGE Therapeutics Announces First Patient Treated Under Phase 3 Expanded Access Protocol to Evaluate SAGE-547 in Patients with Super-Refractory Status Epilepticus.
Taliglucerase alfa is available to patients with Gaucher disease in the United States under an Expanded Access protocol as well as to patients in several member states of the European Union, Israel and other countries under Named Patient provisions.
An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Manitoba) was granted in February as supplies of the only licensed U.
An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Canada) was granted in February as supplies of the only licensed U.
University of Michigan, Ann Arbor, Michigan, and a principal investigator in the expanded access protocol for metreleptin.
Additional information about the expanded access protocol can be found on clinicaltrials.
We also will amend the PREVEON Expanded Access protocol so that all patients currently in the program who have been randomized to the 120 mg dose will have their dose reduced to 60 mg and all patients entering the program will initiate treatment with 60 mg.
clinical studies in relapsed or refractory MCL have completed enrollment, the expanded access protocol provides that opportunity.
The Company continues to make taliglucerase alfa available to Gaucher patients in the United States under an Expanded Access protocol, as well as to patients in the European Union, Israel and other countries under Named Patient provisions.
Taliglucerase alfa will continue being provided to Gaucher patients in the United States under an Expanded Access protocol, as well as to patients in the European Union, Israel and other countries under Named Patient provisions.
The third is an Expanded Access protocol with cost recovery allowing emergency treatment of patients who do not qualify for the first two protocols.
A summary of this expanded access protocol and drug availabilty will soon be available on the FDA website at http://www.
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