Orphan Drug Status definition

Orphan Drug Status means the period during which the Product is approved as an orphan drug.
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Orphan Drug Status means an award of marketing exclusivity under the Orphan Drug Act of 1983 in the United States or any comparable Law in an applicable jurisdiction that provides a period of marketing exclusivity, which designation has not been revoked or expired.
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Orphan Drug Status means, with respect to a Licensed Product, that (i) the Secretary of the FDA has (1) approved an application filed pursuant to section 505(b) of the Federal Food, Drug and Cosmetic Act (“FD&C Act”), (2) issued a certification under section 507 of the FD&C Act, or (3) issued a license under section 351 of the Public Health Service Act for such Licensed Product designated under section 526 of the FD&C Act for a rare disease or condition, and (ii) the Licensed Product has obtained market exclusivity under section 505A of the Food and Drug Administration Modernization Act of 1997.
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Examples of Orphan Drug Status in a sentence

  • Orphan drug statusThe applicant requested Orphan Drug Status in accordance with Article 4 adecies no.

  • Additionally, the FDA has granted Orphan Drug Status and a Rare Pediatric Disease Designation to MC-1 for the treatment of PNPO deficiency.

  • Its lead investigational therapy Multikine® (Leukocyte Interleukin, Injection) is currently in a pivotal Phase 3 clinical trial involving head and neck cancer, for which CEL-SCI has received Orphan Drug Status from the U.S. FDA.

  • NurOwn® has received Fast Track designation from the FDA in ALS and has additionally been granted Orphan Drug Status by the FDA and the EMA.

  • MDNA55 has secured Orphan Drug Status from the United States Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) as well as Fast Track Designation from the FDA for the treatment of rGBM and other types of high grade glioma.

  • If the FDA declines to allow the assignment of any of ENTREMED's Investigational New Drug and/or Orphan Drug Status application(s) to CELGENE, for whatever reason, then ENTREMED's rights under such application(s) will be included in this Agreement as ENTREMED EXISTING TECHNOLOGY RIGHTS and will be licensed to CELGENE in accordance with Section 2 of this Agreement.

  • ENTREMED shall take all further steps necessary or helpful to assign to CELGENE all Orphan Drug Status and Investigational New Drug applications filed by ENTREMED as of the EFFECTIVE DATE, as set forth in Appendix C.

  • Concomitant with this process, Diurnal has been seeking confirmation of Orphan Drug Status for Alkindi in paediatric AI.

  • Multikine has received Orphan Drug Status from the U.S. Food and Drug Administration(FDA) for this indication.

  • It has secured Orphan Drug Status from the FDA and the EMA as well as Fast Track Designation from the FDA.Since the above mentioned clinical trials, there have been many improvements to the CED technology, a drug delivery technique for localized administration of MDNA55 into brain tumors.


More Definitions of Orphan Drug Status

Orphan Drug Status is an exclusive approval to market a therapeutic for the treatment of a human fibrotic disease based upon orphan drug status under the Orphan Drug Act of 1983 in the United States (Pub.L. 97-414, Jan.4, 1983, 96 Stat. 2049) or any corresponding or similar non-U.S. statutes, granted by the U.S. Food and Drug Administration (“FDA”), the Committee on Proprietary Medicinal Products (“CPMP”) or other Regulatory Agencies in the Territory to InterMune for the anti-fibrotic uses of Pirfenidone for such disease.
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Related to Orphan Drug Status

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

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Criminal drug statute means a Federal or non-Federal criminal statute involving the manufacture, distribution, dispensing, possession or use of any controlled substance.

  • ANDA means Abbreviated New Drug Application.

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Covered drug means any prescription drug that:

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

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

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

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

  • 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.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

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

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Generic Drug means a Prescription Drug that is medically equivalent to a Brand Name Drug as determined by the FDA. It meets the same standards as a Brand Name Drug for purity, safety, strength and effectiveness and is manufactured and sold under its chemical, common, or official name.

  • 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.

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.