Breakthrough Designation definition

Breakthrough Designation means designation of a drug as a breakthrough therapy by the NMPA.
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Breakthrough Designation means the designation of a drug as a breakthrough therapy by the FDA pursuant to Section 506(a) of the Federal Food Drug and Cosmetic Act (21 U.S.C. §356(a)), as amended by Section 902 of the Food and Drug Administration Safety and Innovation Act and as may be amended further from time to time.
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Breakthrough Designation means designation by the FDA as a breakthrough therapy pursuant to 21 U.S.C. section 356 (or its successor).
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More Definitions of Breakthrough Designation

Breakthrough Designation means, with respect to a Product, that such Product satisfies the requirements for a “breakthrough therapy”, as set forth in 21 U.S.C. § 356, as amended by § 902 of the Food and Drug Administration Safety and Innovation Act.
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Breakthrough Designation means a designation by the FDA of a drug as a breakthrough therapy as set forth in 21 U.S.C. § 356(a) and related FDA guidance, and equivalent rules, regulations and guidance outside of the United States, for example, PRIority MEdicine designation granted by EMA.
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Breakthrough Designation means a Compound has received “breakthrough therapy designation” by the FDA as contemplated by Title IX of the United States Food and Drug Administration Safety and Innovation Act of 2012.
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Breakthrough Designation means a drug as defined by FDASIA Section 902 that: (a) intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and (b) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development;
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Related to Breakthrough 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).

  • Step therapy means a program for Insureds who take Prescription Drugs for an ongoing medical condition, such as arthritis, asthma or high blood pressure, which ensures the Insured receives the most appropriate and cost-effective drug therapy for their condition. The Step Therapy program requires that before benefits are payable for a high cost Covered Drug that may have initially been prescribed, the Insured try a lower cost first-step Covered Drug. If the prescribing Physician has documented with SHL why the Insured’s condition cannot be stabilized with the first-step Covered Drug, SHL will review a request for Prior Authorization to move the Insured to a second-step drug, and so on, until it is determined by SHL that the prescribed Covered Drug is Medically Necessary and eligible for benefit payment.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

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

  • Statewide popular election means a general election in which votes are cast for

  • Conversion therapy means any practice or treatment as defined in § 54.1-2409.5 A of the Code of Virginia.

  • Technology Transfer Agreement has the meaning given in Section 2.2(a).

  • Statewide special election means a special election called by the governor or the

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

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Airline Designator Code means the two-characters or three letters, which identify particular air carriers.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • 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.

  • Designated Center means a State Development and Redevelopment Plan Center as designated by the State Planning Commission such as urban, regional, town, village, or hamlet.

  • Subordinate joint force commander means a sub-unified commander or joint task force commander.

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

  • 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.

  • Universal design means the design of products, environments, programmes and services to be usable by all people, to the greatest extent possible, without the need for adaptation or specialized design. “Universal design” shall not exclude assistive devices for particular groups of persons with disabilities where this is needed.

  • Preferred Provider Organization (PPO) means a health insurance issuer's or carrier's insurance policy that offers covered health care services provided by a network of providers who are contracted with the issuer or carrier (“in-network”) and providers who are not part of the provider network (“out-of-network”).

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

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Participating Home Infusion Therapy Provider means a Home Infusion Therapy Provider who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Natural channel design concepts means the utilization of engineering analysis and fluvial geomorphic processes to create, rehabilitate, restore, or stabilize an open conveyance system for the purpose of creating or recreating a stream that conveys its bankfull storm event within its banks and allows larger flows to access its bankfull bench and its floodplain.