Product Studies definition

Product Studies means clinical, preclinical, safety, and other studies that are designed to support FDA or other Governmental Authority approval for marketing of Products. For the avoidance of doubt, Product Studies shall not include [**], but shall include [**].
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Product Studies means clinical studies, pre-clinical studies, safety studies, epidemiological studies, modeling and pharmacoeconomic studies, in each case including any ancillary or incidental development, investigation or research schemes pertaining thereto, that are designed (a) to support Regulatory Approval for the Products or (b) to support publications, Promotional and educational activities, future labeling changes or new Indications for the Products.
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Product Studies means clinical studies, pre-clinical studies, safety studies, epidemiological studies, modeling and pharmacoeconomic studies, in each case including any ancillary or incidental development, investigation or research schemes pertaining thereto, that are designed (a) to support Regulatory Approval for the Product or (b) to support publications, **** Material omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Exchange Act of 1934. Material filed separately with the Securities and Exchange Commission. promotional and educational activities, future labeling changes or new Indications for pafuramidine.
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Examples of Product Studies in a sentence

  • Contact the Engineer of Technical and Product Studies at the Bureau of Materials and Physical Research for additional information on the IHDC process.

  • Exploring barriers to teaching behavioral and social sciences in medical education.

  • Advancis shall own in their entirety (a) all clinical data and reports related to Product Studies including clinical trials for the Products and (b) all NDAs and other Regulatory Approvals for Products.

  • Immtech shall own, in its entirety, all clinical data and reports related to Product Studies including clinical trials for the Product.

  • For the quantities of Product to be supplied by Immtech, BioAlliance shall pay Immtech the Transfer Price, except that, with respect to any quantities of Product that BioAlliance or its Affiliates or sublicensees purchases for use in Product Studies in the Territory or distributes as samples to persons in the medical profession, such quantities shall be supplied at the Direct Cost.

  • Neither party shall make any material change to any annual Developmental Plan, or any of the Developmental Program Product Studies, without the prior approval of the DC, and all Development Plans and Development Costs provided therein shall be consistent with the terms of this Agreement.

  • The society is also committed to the preservation and conservation of such practices for future generation.After the grand success of the 12th International Congress of International Society for Ethnopharmacology (ISE) organized by the School of Natural Product Studies, Jadavpur University Kolkata in February 2012, the Society for Ethnopharmacology, India (SFE – India) was constituted in August 2013.

  • Dr. Pulok Kumar Mukherjee is Director School of Natural Product Studies Dept.

  • Effects of Relative Humidity and CO(g) on the O-3-Initiated Oxidation Reaction of Hg-0(G): Kinetic & Product Studies.

  • Doctors, Scott Sherman, Omar El-Shahawy, and Bianca Dearing of NYU Langone’s Center for Alternative Tobacco Product Studies (CATS) discussed their ECRIP projects about Tobacco use and alternate tobacco products in New York State.The research fellows discussed their projects, how ECRIP has helped them forge and expand their research experience, and how their projects will help further build clinical research capacity on tobacco and alternate tobacco products in New York.


More Definitions of Product Studies

Product Studies means clinical studies, pre-clinical studies, safety studies, epidemiological studies, modeling and pharmacoeconomic studies, in each case including any ancillary or incidental development, investigation or research schemes pertaining thereto, that are designed (a) to support Regulatory Approval for the Product or (b) to support publications, promotional and educational activities, future labeling changes or new Indications for pafuramidine.
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Related to Product Studies

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

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

  • 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;

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

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