Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:
New Drug Application or “NDA” means a new drug application filed with a Regulatory Authority (not including pricing and reimbursement approval), that is analogous to the new drug application with the United States Food and Drug Administration described in 21 C.F.R. § 314.
Legend drugs means any drugs which are required by state
Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.
controlled drug means an article or substance prescribed under a regulation to be a controlled drug.
Restricted use pesticide means any pesticide or device which, when used as directed or in accordance with a widespread and commonly recognized practice, the director determines, subsequent to a hearing, requires additional restrictions for that use to prevent unreasonable adverse effects on the environment including people, lands, beneficial insects, animals, crops, and wildlife, other than pests.
Drug addiction means a disease characterized by a
Chemical dependency means the physiological and psychological addiction to a controlled drug or substance, or to alcohol. Dependence upon tobacco, nicotine, caffeine or eating disorders are not included in this definition.
Narcotic drug means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.
Legal drug means any drug, including any prescription drug or over-the-counter drug, that has been legally obtained and that is not unlawfully sold or distributed.
Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.
Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:
Dangerous drug means any of the following:
Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.
Prescription drugs means drugs, medicine and controlled substances which by law can only be prescribed for human use by persons authorized by law.
Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.
Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.
Controlled dangerous substance means a drug, substance, or
Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;
Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.
Infectious Disease means an illness that is capable of being spread from one individual to another.
Additional Indication means any indication other than the Initial Indication.
Designated chemical dependency specialist means a person
Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.
Cosmetic Surgery means any Surgery, service, Drug or supply designed to improve the appearance of an individual by alteration of a physical characteristic which is within the broad range of normal but which may be considered unpleasing or unsightly, except when necessitated by an Injury.