compassionate use

compassionate use

Pharmacology The use of an agent to treat Pts for whom conventional therapies have failed, or for whom no other drug exists; CU refers to the use of an agent on humanitarian grounds before it has received regulatory–FDA–approval

compassionate use

(kŏm″pash′ŏn-ăt)
The administration of investigational (i.e., as yet unapproved) drugs to a patient in a special circumstance in which it is felt that the drug may be lifesaving or effective when no other therapy would be. The procedure requires the treating physician to contact either the Food and Drug Administration or the drug manufacturer to obtain permission.
References in periodicals archive ?
"The government shall however aim to achieve a balance in the national drug control program so that people with legitimate medical needs are not prevented from being treated with adequate amounts of appropriate medications, which include the use of dangerous drugs." Compassionate use
M2 EQUITYBITES-January 23, 2018-Genmab announces Novartis' intention to transition the commercial availability of Arzerra to limited availability via compassionate use programmes
M2 PHARMA-January 23, 2018-Genmab announces Novartis' intention to transition the commercial availability of Arzerra to limited availability via compassionate use programmes
He said the Senate could only commit to study the compassionate use of medical cannabis and that this, if ever, would entail the amendment of the compassionate use provision of Republic Act No.
The Texas Compassionate Use Act legalized the selling of a specific kind of cannabis oil derived from marijuana plants for a very small group of customers: epilepsy patients whose symptoms have not responded to federally approved medication.
"Compassionate use involves unidentified risk and may create a false sense of hope in patients," according to the standards set by the Eli Lilly pharmaceutical firm.
The decision supports Proposition 215, the Compassionate Use Act, a 1996 state law that sought to ensure that patients and their primary caregivers who obtain and use marijuana for medical purposes upon the recommendation of a physician are not subject to criminal prosecution or sanction.
A combination of quinupristin and dalfopristin, Synercid has been available for a few years for compassionate use. Marketing approval will change how the drug is used and how infections by vancomycin-resistant enterococci (VRE) are treated, predicted Dr.
Washington, D.C., lawyer Jonathan Emord represents patients petitioning the FDA's Center for Drug Evaluation and Research for "compassionate use" exceptions or slots in the clinical trials.
Rescheduling would simply encourage much-needed research, they say, and might open the door to "compassionate use." Under its compassionate use rule, the FDA allows unapproved drugs to be prescribed when effective alternatives are not available.
Novartis (VTX: NOVN) has revealed its intention to transition Arzerra (ofatumumab), a treatment for certain chronic lymphocytic leukaemia (CLL) indications, from commercial availability to limited availability via compassionate use programmes in all markets except the United States, Genmab A/S (CPH: GEN) announced on Monday.
The FDA provides some access to drugs and medicines that are not registered in the Philippines for 'compassionate use,' Ubial explained.