Prescription drug product definition

Prescription drug product means a brand name drug, a generic
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Prescription drug product means a brand name drug, a generic drug, a biologic, or a
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Prescription drug product means a drug or biological product receiving approval under a drug
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Examples of Prescription drug product in a sentence

  • Prescription drug product advertisements, those that name a prescription drug and discuss its benefits and risks, must include certain key information, including the name of the drug (both the brand and generic names), at least one FDA-approved use for the drug, and the most significant risks associated with use of the drug.

  • Prescription drug product labels may be redesigned less frequently, but there is evidence that numerous labeling changes occur.

  • Prescription drug product advertisements, those that name a prescription drug and discuss its benefits and risks, must include certain key information, including the name of the drug (both the brand and generic names), at least one FDA-approved use for the drug, and the most significant risks associated with use of the drug.

  • He noted that during the 2008 Forum meeting, the premier of Niue focused on the importance of marine resources, observing that their exclusive economic zone (EEZ) was effectively their fish farm.


More Definitions of Prescription drug product

Prescription drug product means a drug or biological product receiving approval under a drug application pursuant to 21 U.S.C. Section 355(b) or under a biologics license application approved under 42 U.S.C. Section 262.
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Prescription drug product means a prescription drug
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Prescription drug product means any of the following products:
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Related to Prescription drug product

  • Prescription drug means any drug required by federal law or regulation to be dispensed only

  • Prescription drug order means a lawful order from a practitioner for a drug or device for a specific patient, issued for a legitimate medical purpose within the prescriber’s course of legitimate practice and including orders derived from collaborative pharmacy practice.

  • Nonprescription drug or "over-the-counter drug" means any

  • Nonprescription drugs means nonnarcotic medicines or drugs which may be sold without a prescription and are prepackaged and labeled for use by the consumer in accordance with the requirements of the statutes and regulations of this state and the federal government;

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

  • 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;

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia

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

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical or biological ingredient as further set forth in the applicable Product Manufacturing Plan.

  • Labeling means all labels and other written, printed, or graphic matter on an article or any of its

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

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Drug addiction means a disease characterized by a

  • 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.

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

  • Prescription device means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, and any component part or accessory, which is required under federal or state law to be prescribed by a practitioner and dispensed by or through a person or entity licensed under this chapter or exempt from licensure under this chapter.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 CFR § 314, or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the US.