FDA Regulated Product definition

FDA Regulated Product means any product or component including, without limitation, any medical device, that is studied, used, held or offered for sale for human research or investigation or clinical use.
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FDA Regulated Product means and includes any of Issuer’s approved products, product candidates, or any components thereof that are subject to the FDCA and other Laws administered by the FDA.
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FDA Regulated Product means and includes any product or component that is subject to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. and its implementing regulations and/or other laws administered by the FDA.
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Examples of FDA Regulated Product in a sentence

  • Draft Guidance for Industry: Considering Whether an FDA Regulated Product Involves the Application of Nanotechnology 2011.

  • FDA is announcing the availability of a draft guidance for industry entitled ‘‘Considering Whether an FDA- Regulated Product Involves the Application of Nanotechnology’’.

  • This guidance finalizes the draft guidance, entitled “Draft Guidance for Industry: Considering Whether an FDA- Regulated Product Involves the Application of Nanotechnology,” which was issued in June, 2011.

  • However, the Planning Statement does not address the fact that the proposed development would cover approximately half of the Green Space with built form and parking and turning areas.

  • The anti-harassment policy and procedures are intended to provide fair and equitable treatment of both the complainant and the alleged harasser.All students and employees are responsible to determine if they can abide by Dordt’s sexual standards and conduct policy.

  • The Company’s FDA complaint handling and adverse event reporting systems relating to all FDA Regulated Products have been made available for review by Purchaser and the Company has made available to Purchaser complete and correct information about all FDA Regulated Product returns because of warranty or other problems and about all mandatory and voluntary adverse event reports.

  • IdentifySensors is responsible for the initial assessment and, if appropriate, initial investigation of Complaints alleging an event that could be reportable to the FDA under FDA Regulated Product reporting regulations, and/or another Regulatory Agency as required.

  • Medical benefits, if any, and payment for such Treatment is the responsibility of the undersigned parent(s)/legal guardian(s).

  • The Issuer has disclosed to the Purchaser any and all currently unresolved material complaints and other notices, actions, or Orders relating to any alleged lack of safety, efficacy, regulatory compliance, or any other allegations of any violation of any applicable Laws, or Order of any court or competent tribunal, by the Issuer or any of its Affiliates, or for any FDA Regulated Product that, either individually or in the aggregate, may result in a Material Adverse Effect.

  • FDA Regulated Product Factory RequirementFactories producing product that is regulated by the FDA are required to have a valid GMP or BRC certificate.


More Definitions of FDA Regulated Product

FDA Regulated Product shall have the meaning ascribed to such term in Section 3.1(jj).
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FDA Regulated Product means any product or component including any medical device, that is studied, used, held or offered for sale for human research or investigation or clinical use.
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FDA Regulated Product means each existing Company platform, program, product, product candidate or service subject to regulation by the FDA under Healthcare Regulatory Laws or any other comparable Law including (i) approved and investigational drugs, biological products, medical devices (including in vitro diagnostic tests and laboratory developed tests), and combination products and any raw materials or components of such drugs, biological products, medical devices, or combination products; and (ii) any products or services used in the design, monitoring, and control of manufacturing processes and facilities that are subject to Healthcare Regulatory Laws, including Current Good Manufacturing Practice regulations and/or Quality System regulations.
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FDA Regulated Product means and include any product or component that is cleared or approved by the FDA for sale for human use.
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FDA Regulated Product means any product or component that is studied, used held or offered for sale for human or animal research or
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FDA Regulated Product means any drug, medical device or combination product produced, sold, distributed or marketed by the Company as of the date of this Agreement, that is or is required to be cleared or approved (including approval for research, investigation or clinical use) by the FDA, and that is studied, used, held or offered for sale for human use, including for human research or investigation or clinical use (provided that the term FDA Regulated Product shall not include INFASURF, which was marketed by the Company pursuant to the co-promotion agreement by and between Forest Laboratories, Inc. and the Company.
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Related to FDA Regulated Product

  • regulated product means a consumer product for which a VOC standard is specified in section 94509(a), and

  • Designated Products means products provided by Motorola to Licensee with which or for which the Software and Documentation is licensed for use.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Reformulated Products means Products that contain concentrations less than or equal to 0.1% (1,000 parts per million (ppm)) of DEHP when analyzed pursuant to U.S. Environmental Protection Agency testing methodologies 3580A and 8270C or other methodology utilized by federal or state government agencies for the purpose of determining the phthalate content in a solid substance.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Regulated Materials means any hazardous, toxic or dangerous waste, substance or material, the generation, handling, storage, disposal, treatment or emission of which is subject to any Environmental Law.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Related Products means (i) with respect to Resource Adequacy Benefits that portion of the Resource Adequacy Benefits that are in excess of those Resource Adequacy Benefits used by Seller or by a Site Host, both in connection with the Host Site, to meet a known and established, at the point in time when the Resource Adequacy Benefits are to be used, resource adequacy obligation under any Resource Adequacy Ruling, and (ii) any Green Attributes, Capacity Attributes and all other attributes associated with the electric energy or capacity of the Generating Facility (but not including any Financial Incentives) that are in excess of those Green Attributes, Capacity Attributes or other attributes used, or retained for future use, by Seller or a Site Host, both in connection with the Host Site, to meet a known and established, at the point in time when the relevant attribute(s) are to be used or retained, obligation under Applicable Law.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Petroleum product means crude oil, petroleum, refined petroleum products, byproducts and intermediate feed stocks, and other energy-related commodities, including, without limitation, blend components commonly used in the petroleum industry to improve characteristics of, or meet governmental or customer specifications for, petroleum or refined petroleum products.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Marijuana-infused products means products that contain marijuana or marijuana extracts and are intended for human use. The term "marijuana-infused products" does not include useable marijuana.

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.