Developed by the manufacturer definition

Developed by the manufacturer means, for a prescription drug, that its research and development costs were funded by the manufacturer in whole or in part through Phase I, II, or III trials as defined in 21 CFR 312.21.
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Related to Developed by the manufacturer

  • Nonparticipating manufacturer means any tobacco product manufacturer that is not a participating manufacturer.

  • Participating manufacturer means that term as defined in the master settlement agreement.

  • Third Party Manufacturer means (i) a Third Party whose primary business is contract manufacturing, or (ii) a Third Party who has a contractual arrangement with Licensee or with a sublicensee of Licensee that includes manufacturing of Client Product and/or Drug Product by such Third Party for Licensee or such sublicensee.

  • Non-Participating Manufacturer means any Tobacco Product Manufacturer that is not a Participating Manufacturer.

  • Manufacturer means the person or body who is responsible to the approval authority for all aspects of the type approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stage of the construction of the vehicle, system, component or separate technical unit which is the subject of the approval process.