Orphan Designation definition

Orphan Designation means the designation of a drug as a drug for a rare disease or condition pursuant to Section 526 of the Act.
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Orphan Designation means a special status granted, under the Orphan Drug Act, to a drug or biological product to treat a rare disease or condition,
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Orphan Designation means the grant by FDA of a request for orphan-drug designation under Section 526 of the Act, as amended (or its successor regulation), for a drug for a particular Orphan Indication.
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Examples of Orphan Designation in a sentence

  • To the extent not previously assigned to ACORDA, RUSH hereby conveys, assigns and transfers to ACORDA, free and clear of all claims, liens and encumbrances and contractually imposed restrictions, all right, title and interest in and to the Rush Orphan Designation.

  • RUSH shall assist and cooperate with ACORDA in the submission of any letters or other documents to the FDA required or requested in connection with the change in ownership of the Rush Orphan Designation from RUSH to ACORDA.

  • Applicants1 including the Sponsor2 of an Orphan Designation (OD) or persons acting on their behalf, must have an active EMA user account and must be subsequently registered with an IRIS user access role of “IRIS Industry Manager” (affiliated to one or more organisations, if submitting on behalf of an organisation), and/or “IRIS Individual User” (if submitting as an individual).

  • OSIRIS grants to JCR, during the term of this Agreement, a right of first negotiation to obtain from OSIRIS the exclusive right, in the Territory, to develop, register, use, make, have made, import, export, offer to sell, sell and have sold Products for a use that has an Orphan Designation in the Territory.

  • If orphan designation is being sought, this should be indicated, and for pending applications the Agency’s Orphan Designation Procedure number should be provided.

  • The United States Food and Drug Administration, or the FDA, has granted anabasum Orphan Designation as well as Fast Track Status for both cystic fibrosis and systemic sclerosis.

  • If orphan designation is being sought this should be indicated and for pending applications the EMEA Orphan Designation Procedure Number should be provided.

  • The European Medicines Authority, or the EMA, has granted anabasum Orphan Designation for both cystic fibrosis and systemic sclerosis.

  • If orphan designation is being sought, this should be indicated, and for pending applications the EMA’s Orphan Designation Procedure number should be provided.

  • Fast Track designationis intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.The European Medicines Agency has also granted Orphan Designation for trofinetide in both Rett syndrome and Fragile X syndrome.


More Definitions of Orphan Designation

Orphan Designation means any treatment of a disease which afflicts less than 50,000 patients per year in the Territory and /or the use in such patients and that meets the criteria for orphan designation application established by the governing health care authority in the Territory other than the Field.
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Orphan Designation means the orphan designation EU/3/16/1778 granted by the European Commission on 18 November 2016.
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Orphan Designation means orphan status provided to pharmaceuticals, biologics, medical devices and medical food intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders meeting certain criteria in the United States specified in the Orphan Drug Act and FDA’s implementing regulations at 21 CFR Part 316, and including foreign equivalents thereof, including, criteria provided by the European Medicine’s Agency’s Committee for Orphan Medicinal Products (COMP), the Australian Government’s Department of Health, Therapeutic Goods Administration, and the Ministry of Health, Labour and Welfare of Japan.
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Related to Orphan Designation

  • Type designation means a combination of letters and numerals assigned by the Government to a major end item, assembly or subassembly, as appropriate, to provide a convenient means of differentiating between items having the same basic name and to indicate modifications and changes thereto.

  • Share Designation has the meaning assigned to such term in ‎Section 3.2(b).

  • Series Designation has the meaning assigned to such term in Section 3.03(a).

  • Secured Party Designation Notice means a notice from any Lender or an Affiliate of a Lender substantially in the form of Exhibit H.

  • Certificate of Designations means the Certificate of Designations or comparable instrument relating to the Designated Preferred Stock, of which these Standard Provisions form a part, as it may be amended from time to time.

  • Preferred Proponent(s means the Proponent(s) selected by the Evaluation Team to enter into negotiations for a Contract;

  • Preferred Proponent means the Proponent that is invited into negotiations in accordance with the evaluation process set out in this RFP;

  • Beneficiary designation means the naming in a governing instrument of a beneficiary of an insurance or annuity policy, of an account with POD designation, of a security registered in beneficiary form (TOD), of a pension, profit-sharing, retirement, or similar benefit plan, or of another nonprobate transfer at death.

  • National Medical Support Notice or “NMSN” shall mean a notice that contains the following information:

  • Restated Certificate of Incorporation means the Restated Certificate of Incorporation of the Company, as amended.

  • Series B Certificate of Designations means the certificate of designations establishing the terms of the Series B Preferred Stock.

  • Series B Certificate of Designation means the Certificate of Designation of Series B Cumulative Convertible Preferred Shares of the Company as in effect on the date hereof.

  • Restated Certificate means the Company’s Amended and Restated Certificate of Incorporation, as amended and/or restated from time to time.

  • Designation has the meaning provided in Section 4.17(a).

  • Amended and Restated Certificate of Incorporation means the Amended and Restated Certificate of Incorporation of the Company, as in effect as of the Effective Date.

  • Beneficiary Designation Form means the form established from time to time by the Plan Administrator that the Executive completes, signs and returns to the Plan Administrator to designate one or more Beneficiaries.

  • Board Designee means an employee of the Board who has been given authority by the Board to carry out a function for the Board (e.g., the Clerk, Assistant Clerk of the Board, or hearing officer).

  • Unit Designation has the meaning set forth in Section 3.2(b).

  • Certificate of Designation means the Certificate of Designation to be filed prior to the Closing by the Company with the Secretary of State of Delaware, in the form of Exhibit A attached hereto.

  • Traditional member of the National Guard or federal reserves means an active member of the Selected Reserve subject to mobilization and deployment for which he or she attends monthly and annual training periods.

  • Series A Certificate of Designations means the Certificate of Designations of Series A Preferred Stock of the Company.

  • Designation Agreement means a designation agreement entered into by a Lender (other than a Designated Bidder) and a Designated Bidder, and accepted by the Agent, in substantially the form of Exhibit D hereto.

  • Series A Certificate of Designation means the Certificate of Designation of Series A Cumulative Convertible Preferred Shares of the Company as in effect on the date hereof.

  • Registered design in this Act shall mean a design for which a design registration has been granted.

  • Partnership Unit Designation shall have the meaning set forth in Section 4.2.A hereof.

  • Designation Notice means a notice from any Lender or an Affiliate of a Lender substantially in the form of Exhibit I.