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
Use or possess medical cannabis, unless he or she has complied Illinois’ Compassionate Use of Medical Cannabis Act and district policies.
Compassionate Use of Remdesivir for Patients with Severe Covid-19.
Administration of Medical CannabisIn accordance with the Compassionate Use of Medical Cannabis Program, qualifying students are allowed to utilize medical cannabis infused products while at school and school events.
Use or possess medical cannabis, unless he or she has complied with Illinois' Compassionate Use of Medical Cannabis Act and district policies.
Advise them of any plausible theories of liability they may pursue; whether they have a realistic prospect to prevail against the Board; and if so, what kind of remedies they would be likely to obtain.
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 use of a Formulated Product in a particular country in the European Territory for alleviating or curing a cancer indication in humans, prior to Registration of that product in that country for that indication (e.g. named patient sales).
Compassionate Use means the use of a Licensed Product as an investigational drug (prior to Marketing Approval) in accordance with applicable Law outside of a Clinical Study to treat a patient with a serious or life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONFIDENTIAL TREATMENT REQUESTED
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. The use of an Investigational Medicinal Product for an unapproved indication, in circumstances where a Party has supplied it for that use in response to a bona fide unsolicited request from a healthcare professional assuming responsibility for that use by their patient.
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.