Regulatory Affairs Branch definition

Regulatory Affairs Branch means the Regulatory Affairs Branch, CTEP, DCTD, NCI.
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Regulatory Affairs Branch means the Regulatory Affairs Branch of DPMCDA.
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Examples of Regulatory Affairs Branch in a sentence

  • Abstracts to be presented by NCI investigators will be sent to NCI’s Regulatory Affairs Branch [xxxxxxx@xxxx.xxx.xxx] for forwarding to Collaborator as soon as they are received, preferably no less than three days prior to submission, but prior to presentation or publication, to allow for preservation of U.S. or foreign patent rights.

  • Manuscripts to be submitted for publication by NCI investigators will be sent to NCI’s Regulatory Affairs Branch [xxxxxxx@xxxx.xxx.xxx] for forwarding to Collaborator for review as soon as they are received and in compliance with the timelines outlined above.

  • A letter from the Chief Planning and Regulatory Affairs Branch, Department of Agriculture, transmitting the Department’s final rule — Supplemental Nutrition Assist- ance Program, Regulation Restructuring: Issuance Regulation Update and Reorganiza- tion To Reflect the End of Coupon Issuance Systems (RIN: 0584-AD48) received January 21, 2011, pursuant to 5 U.S.C. 801(a)(1)(A); to the Committee on Agriculture.

  • Email: anshers@mail.nih.gov The Regulatory Affairs Branch will then distribute them to Collaborator(s).

  • Manuscripts to be submitted for publication and proposed abstracts or presentations by Approved Investigators will be sent to NCI’s Regulatory Affairs Branch at NCI CTEP Publications for forwarding to NCI Collaborator for review as soon as they are received and in compliance with the timelines outlined above.

  • OPCRO, which includes the Regulatory Affairs Branch, Clinical Research Resources Branch and the Protection of Participants, Evaluation and Policy Branch, provides division-wide oversight and support services for DAIDS-sponsored clinical research sites to ensure compliance with applicable regulations, standards and good clinical practice guidelines; the safety and welfare of study participants; and the quality and integrity of the study.

  • Abstracts to be presented by NCI Investigators will be sent to NCI’s Regulatory Affairs Branch [XXXXXXXxxxx@xxxx.xxx.xxx] for forwarding to Collaborator as soon as they are received, preferably no less than three (3) days prior to submission, but prior to presentation or publication, to allow for preservation of U.S. or foreign patent rights.

  • Abstracts to be presented by Approved Investigators will be sent to NCI’s Regulatory Affairs Branch [XXXXXXXxxxx@xxxx.xxx.xxx] for forwarding to Collaborator as soon as they are received, preferably no less than seven (7) business days prior to submission, but prior to presentation or publication, to allow for preservation of U.S. or foreign patent rights.

  • Manuscripts to be submitted for publication by Approved Investigators will be sent to NCI’s Regulatory Affairs Branch [XXXXXXXxxxx@xxxx.xxx.xxx] for forwarding to Collaborator for review as soon as they are received and in compliance with the timelines outlined above.

  • In addition, several groups within the Office of the Director collaborate to support IMPAACT Network functions, including the Office of Clinical Site Oversight (OCSO), which includes the Pharmaceutical Affairs Branch (PAB) and Monitoring Operations Branch (MOB), and the Office for Policy in Clinical Research Operations (OPCRO), which includes the Regulatory Affairs Branch (RAB).

Related to Regulatory Affairs Branch

  • 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.

  • 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.

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • 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.

  • 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.

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

  • 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.

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • 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;

  • 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.

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

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • 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;

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • 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;

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • 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.

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

  • 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.

  • Professional development means training programs for

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

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.