Stage-Four Advanced, Metastatic Cancer means a cancer that has spread from the primary or original site of the cancer to nearby tissues, lymph nodes, or other areas or parts of the body.
Cancer means the presence of one or more malignant tumours including Hodgkin’s disease, leukaemia and other malignant bone marrow disorders, and characterised by the uncontrolled growth and spread of malignant cells and the invasion and destruction of normal tissue, but does not include the following:
Opioid antagonist means a drug that binds to opioid
thalassemia means a group of inherited disorders characterised by reduced or absent amounts of haemoglobin.
Receptor means enclosed spaces, conduits, protected groundwater sources, drinking and non-drinking water wells, surface water bodies, and public water systems which when impacted by chemicals of concern may result in exposure to humans and aquatic life, explosive conditions or other adverse effects on health, safety and the environment as specified in these rules.
Vector means an insect or other animal which normally transports an infectious agent that constitutes a public health risk;
Infection means the entry and development or multiplication of an infectious agent in the body of humans and animals that may constitute a public health risk;
Opioid means a drug that produces an agonist effect on opioid receptors and is indicated or used for the treatment of pain.
Therapeutic care means services provided by licensed or certified speech pathologists, Occupational Therapists and Physical Therapists.
Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.
COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.
Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.
coronavirus means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);
Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications, or derivatives thereof, but excluding single variable domains (heavy or light) of such antibodies.
Pivotal Trial means a clinical study in humans of the efficacy and safety of a Licensed Product that is prospectively designed to demonstrate with statistical significance that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product and would satisfy the requirements of 21 CFR 312.21(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States.
Prosthesis means an artificial substitute for a missing body part.
Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.
Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.
Cannabinoid means any of the chemical compounds that are the active constituents of marijuana.
Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.
Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
Infectious Disease means an illness that is capable of being spread from one individual to another.
Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed Product.
Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.
Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.
Opioid treatment program means a detoxification or maintenance treatment program which is required to report patient identifying information to the central registry and which is located in the state.