Valid Scientific Evidence definition

Valid Scientific Evidence means evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well- documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.
Valid Scientific Evidence means evidence from well-controlled investigations,
Valid Scientific Evidence means evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well- documented case histories conducted by qualified experts, or reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance to substantiate that a representation is true.

Examples of Valid Scientific Evidence in a sentence

  • However, for Post- Effective Date Urogynecologic Surgical Mesh, BARD may, in any Marketing Materials, represent or imply that such Urogynecologic Surgical Mesh is “soft” or that it has “multidirectional elasticity” within the body after implantation or use any other phrases having an equivalent meaning, if such statement is supported by Valid Scientific Evidence.

  • However, for Post- Effective Date Urogynecologic Surgical Mesh, BARD may, in any Marketing Materials, representor imply that such Urogynecologic Surgical Mesh is “soft” or that it has “multidirectional elasticity” within the body after implantation or use any other phrases having an equivalent meaning, if such statement is supported by Valid Scientific Evidence.

  • For example, artisans such as weavers, jewellers, shoe makers, brass utensil manufacturers, and stone carvers in the surveyed areas rely on raw materials brought from other regions of India.

  • CODE §§17.41 et seq.3.4. BARD shall not, in any Marketing Materials, make any claim comparing safety or efficacy clinical outcomes with the use of Urogynecologic Surgical Mesh to any non-mesh procedure safety or efficacy clinical outcomes, unless any such representation is supported by Valid Scientific Evidence.

  • However, for Post-Effective Date Urogynecologic Surgical Mesh, BARD may, in any Marketing Materials, represent or imply that Significant Complications can be eliminated with surgical experience or technique alone, if such statement is supported by Valid Scientific Evidence.

  • According to National Grid, it is “abundantly clear” that without the targeted infrastructure projects “the looming supply gap is real” and that the projects are “necessary to avoid future service restrictions.”15 Transco continues to review the scope of NESE to not only meet such gas supply gap but also to address the concerns expressed by New York and New Jersey in their respective CWA Section 401 denials.

  • Brenner et al., Technical Knockout: On the Difference Between Valid Scientific Evidence and “Junk,” LOS ANGELES DAILY JOURNAL, March 31, 1999 at 6.


More Definitions of Valid Scientific Evidence

Valid Scientific Evidence means evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well- documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by
Valid Scientific Evidence means evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well- documented case histories conducted by qualified experts, or reports of significant human

Related to Valid Scientific Evidence

  • Competent and reliable scientific evidence means tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Biological diversity means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Merck has the meaning set forth in the preamble.

  • Public research university means Rutgers, The State University

  • Physical therapy licensing board or "licensing board" means the agency of a state that is responsible for the licensing and regulation of physical therapists and physical therapist assistants.

  • 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.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Therapeutic school means a residential group living facility:

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

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Peer-reviewed medical literature means a scientific study published only after having been critically

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Objective medical evidence means reports of examinations or treatments; medical signs which are anatomical, physiological, or psychological abnormalities that can be observed; psychiatric signs which are medically demonstrable phenomena indicating specific abnormalities of behavior, affect, thought, memory, orientation, or contact with reality; or laboratory findings which are anatomical, physiological, or psychological phenomena that can be shown by medically acceptable laboratory diagnostic techniques, including but not limited to chemical tests, electrocardiograms, electroencephalograms, X-rays, and psychological tests;

  • Clinical staff means persons who work in a hospital whose duties include the personal care or medical treatment of patients. “Clinical staff” includes, but is not limited to, credentialed physicians, physicians’ assistants, nurses, nursing aides, medical technicians, therapists, and other individuals involved in the personal care or medical treatment of patients.

  • Licensed mental health professional or "LMHP" means a physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed substance abuse treatment practitioner, licensed marriage and family therapist, certified psychiatric clinical nurse specialist, licensed behavior analyst, or licensed psychiatric/mental health nurse practitioner.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • 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.

  • 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;

  • Modern biotechnology means the application of:

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Soil scientist means an individual duly qualified in accordance with standards set by the Federal Office of Personnel Management.