Orphan Drug Product definition

Orphan Drug Product means a Licensed Product for a specific Indication for which the FDA has granted “Orphan-drug exclusive approval” as defined in 21 CFR Part 316 or which has been granted orphan drug exclusivity under similar regulations in any Major Market or other foreign jurisdiction.
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Orphan Drug Product means, with respect to a given Product sold in a given country of the Territory by MedImmune, its Affiliate or Sublicensee, a product sold by a Third Party in such country that is approved as an orphan drug under the Orphan Drug Action of 1983, as amended (or successor law or regulation), or equivalent regulatory approval granted by another Regulatory Authority.
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Examples of Orphan Drug Product in a sentence

  • We tested the output of this tool with TinyGarble’s compiler (Section 3.3.4), but were unable to run any examples; we weren’t able to determine whether the errors were due to circuit generation by CBMC-GC or execution by TinyGarble.

  • Our primary data source was the FDA Orphan Drug Product designation database.

  • The United States, which had abstained in the vote, hoped that the General Conference would return to consensus in future years, so that those issues might be addressed in a more collaborative and productive manner.

  • We currently have orphan drug exclusivity for certain product candidates, and may seek Orphan Drug Product designation for additional product candidates or indications, which might not be received or provide the intended benefit thereof.Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs.

  • Among the other benefits of Orphan Drug Product Designation are tax credits for certain research and a waiver of the BLA application user fee.A drug with Orphan Drug Product Designation may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received Orphan Drug Product Designation.

  • We also have received Orphan Drug Product designation for GALE-301 and for GALE-302 from the FDA.Generally, if a product with an orphan drug designation subsequently receives the first regulatory approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the EMA or the FDA from approving another marketing application for the same drug for that time period.

  • We have obtained Orphan Drug Product designation for GPS in AML, MPM and MM and for GALE-301 and one for GALE-302.

  • Upon completion of the SUD assessment, the SUD professional shall enter the completion of the SUD assessment in WICS and assign a program type if a program need is determined according to the program assignment chart in II.D.

  • Over its developmental history, Ampligen has received various designations, including Orphan Drug Product Designation (FDA and European Medicines Agency (“EMA”)), Treatment protocol (e.g., “Expanded Access” or “Compassionate” use authorization) with Cost Recovery Authorization (FDA) and “promising” clinical outcome recognition based on the evaluation of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research and Quality).

  • In March 2011, Skinvisible submitted an application to the United States Orphan Drug Division in order to receive an Orphan Drug Product Designation for the Company's product formulated with Invisicare to treat Netherton Syndrome.

Related to Orphan Drug Product

  • 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;

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

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

  • orphan means a child who has no surviving parent caring for him or her;

  • 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.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • FDA means the United States Food and Drug Administration.

  • Nicotine product means a product that contains nicotine and is not any of the following:

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

  • 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.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Licensed Compounds means any EZH2 Compound(s) that is:

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

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

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

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

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

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.