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 ?
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
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.
She was cited by police even though she had a Santa Cruz County-issued medical marijuana card, authorized under the state's Compassionate Use Act, said her attorney, Christina Alvarez, with the American Civil Liberties Union Drug Law Reform Project.
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.
Sure, there's the safety valve of the compassionate use exception," says the congressional staffer who works on the Burzynski case.
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.
When California voters passed the Compassionate Use Act in 1996, the 68-year-old Simi Valley resident just wanted to use the drug he says gives him relief from migraine headaches and symptoms of diabetes.
California's Compassionate Use Act of 1996 largely grew out of the experience of illegal but semi-tolerated "buyer's clubs" that provide marijuana to chemotherapy, AIDS, glaucoma, and chronic pain patients.
com), a development-stage oncology and dermatology biopharmaceutical company, reports continued progress in its compassionate use program for PV-10.
The Compassionate Use Act has created a battleground between advocates and law enforcement.