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  • Draft Guidance for Industry: Considering Whether an FDA Regulated Product Involves the Application of Nanotechnology 2011.

  • This guidance finalizes the draft guidance, entitled “Draft Guidance for Industry: Considering Whether an FDA- Regulated Product Involves the Application of Nanotechnology,” which was issued in June, 2011.

  • FDA is announcing the availability of a draft guidance for industry entitled ‘‘Considering Whether an FDA- Regulated Product Involves the Application of Nanotechnology’’.

  • In the guidance “Considering Whether an FDA- Regulated Product involves the Application of Nanotechnology” [28], it recommends considering several aspects of size and related effects (Table 3), which should apply broadly to all FDA-regulated products including medicinal products and medical devices.In 2011, the European Commission published a recommendation on the definition of a nanomaterial [29].

  • Comments of Consumers Union on the FDA Draft Guidance for Industry; Considering Whether an FDA- Regulated Product Involves the Application of Nanotechnology (Aug.

  • 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 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 shall have the meaning ascribed to such term in Section 3.1(ll).
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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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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 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 any product or component that is studied, used held or offered for sale for human or animal research or
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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.

  • 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.

  • 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.

  • 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

  • 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;

  • 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 gasoline, gasoline−alcohol fuel blends, kerosene, fuel oil, burner oil, diesel fuel oil or used motor oil.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • 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.

  • 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.