Compassionate Use definition
Compassionate Use means the use of a Product as an investigational drug in accordance with applicable Law outside of a clinical trial to treat a patient with a serious or life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.
Compassionate Use means access to unregistered medical products in special or emergency situations. In general, either the patient has a severe or life-threatening illness and existing therapy has failed, or the disease is a rare one for which specialist medicines do not have a local marketing authorization. The medical products are still experimental, or at any rate unproven, and the government is not obliged to fund their supply;
Compassionate Use means the use of a Company Product as an investigational drug in accordance with applicable Law outside of a clinical trial to treat a patient with a serious or life-threatening disease or condition who has no comparable or satisfactory alternative treatment options prior to the receipt of the first Marketing Approval of such Company Product in the country where the patient is treated.
Examples of Compassionate Use in a sentence
On January 18, 2010, the Compassionate Use Medical Marijuana Act (CUMMA) (N.J.
No one will be penalized solely for his or her status as a registered qualifying patient or a registered designated caregiver for purposes of the Compassionate Use of Medical Cannabis Pilot Program Act, 410 ILCS 130/.
Additionally, relevant laws that had been previously omitted are now included, such as the Compassionate Use Medical Marijuana Act, N.J.S.A. 24:6I-1, and self-administration of medication by students for specific medical conditions, N.J.S.A. 18A:40-12.3.
On January 18, 2010, the Compassionate Use Medical Marijuana Act (CUMMA) (N.J.S.A. 24:6I-1 et seq.) was signed into law.
No one will be penalized solelyfor his or her status as a registered qualifying patient or a registered designated caregiver for purposes of the Compassionate Use of Medical Cannabis Program Act, 410 ILCS 130/.
More Definitions of Compassionate Use
Compassionate Use means treatment use of an investigational new drug (as described in 21 CFR §312.34) or emergency use of an investigational new drug (as described in 21 CFR §312.36), or such similar use exemption from the need for formal regulatory approval in the applicable jurisdiction outside of the United States.
Compassionate Use means legally permitted use of a LICENSED TECHNOLOGY in a market where the LICENSED TECHNOLOGY has not been approved for commercial sale, for purposes of (i) treating patients in a single patient trial; or (ii) providing expanded access outside of a clinical trial to patients with serious or life-threatening conditions who do not meet the enrollment criteria for a clinical trial.
Compassionate Use means the use of a Licensed Product as an investigational drug in accordance with Applicable Law outside of a Clinical Trial to treat a patient with a serious or life-threatening disease or condition who has no comparable or satisfactory alternative treatment options, including any managed access programs.
Compassionate Use means use of a product in a particular country in the Territory for alleviating or curing a cancer indication in humans, prior to Registration by Faulding of that product in that country for that indication.
Compassionate Use means (i) providing a LICENSED PRODUCT prior to marketing approval by the United States Food and Drug Administration (FDA) and outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options; (ii) providing a LICENSED PRODUCT or LICENSED SERVICE to public sector entities in developing countries (as defined by the World Bank or International Monetary Fund); (iii) providing a LICENSED PRODUCT or LICENSED SERVICE to indigent individuals and/or individuals without medical health insurance; or (iv) a combination of the preceding (i-iii).
Compassionate Use shall have the meaning set forth in Section 2.10.
Compassionate Use means the use of a Product in accordance with Applicable Laws under compassionate use in expanded access programs to treat the patients who participated as subjects in Study “ME-401-K01,” and “ME-401-K02”. For clarity, nothing in this Termination Agreement shall oblige KKC to perform Compassionate Use.