Clinical Development Programs definition

Clinical Development Programs means the conduct, in the United States and outside the United States, as applicable, of preclinical and clinical activities and filing and prosecution of regulatory applications in support of regulatory approval and regulatory classification in respect of commercial introduction, marketing and sales of the Products.
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Examples of Clinical Development Programs in a sentence

  • Clinical Development Programs for Human Drugs, Biological Products, and Medical Devices for the Treatment and Prevention of Osteoarthritis; p.

  • Furthermore, it may also undermine investment in a SZEF-compatible fleet and instead encourage investments in fossil fuel- derived production of fuels such as hydrogen, ammonia, and methanol.Allowing for out-of-sector offsets9 risks reducing the investment case for in-sector emission reduction solutions by delaying investments and increasing uncertainty around the point at which shipping’s in-sector solutions would be competitive.

  • Clinical Development Programs Rindopepimut Rindopepimut is an immunotherapeutic that targets the tumor-specific molecule epidermal growth factor receptor variant III, or EGFRvIII.

  • The use of international standards such as ICD within supplied clinical metadata is encouraged but will be limited by their use within the source EMR or EHR system.

  • Risk Factors." Clinical Development Programs Glembatumumab Vedotin Glembatumumab vedotin is an antibody-drug conjugate, or ADC, that consists of a fully human monoclonal antibody, CR011, linked to a potent cell- killing drug, monomethyl auristatin E, or MMAE.

  • In C1 districts, outdoor display, temporary outdoor sales, and outdoor storage shall not be permitted.

  • Assessment vendors are subject to change based on recommendations and annual reviews conducted by the Green Dot Education Team. Traditional Classroom Assessments: Quizzes, essays, projects and exams are delivered regularly in classes. Other Assessments: Students are also measured regularly in non-curricular areas such as class attendance and discipline.

  • See "Clinical Development Programs." Cytomegalovirus is one of the most common opportunistic infections in patients with AIDS.

  • In addition, it is also recommended that a dedicated HPA axis trial appropriately designed based on the recommendations from the FDA draft Guidance for Industry (2000) for Allergic Rhinitis: Clinical Development Programs for Drug Products, be undertaken to elucidate the HPA axis effect, if any.

  • Rudolph’s Pediatrics, 20th Edition (1996), section 22.9.1 states that, “the initiation of the adolescent growth spurt precedes the onset of secondary sex characteristics by approximately 1 year in boys and girls.” 4 For recommended inclusion and exclusion criteria for patients with perennial allergic rhinitis, see the draft guidance for industry Allergic Rhinitis: Clinical Development Programs for Drug Products.

Related to Clinical Development Programs

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Development Program means the implementation of the development plan.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Development Plans has the meaning set forth in Section 3.2.

  • Development Plan has the meaning set forth in Section 3.2.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • 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.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • spatial development framework means the Kouga Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.