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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Examples of Breakthrough Designation in a sentence

  • Section 517A of the FD&C Act requires the Center to provide, upon request of a person who is seeking to submit or who has submitted a 510(k), PMA, IDE, HDE, or Breakthrough Designation Request, a “substantive summary” of the scientific and regulatory rationale for any 517A decision regarding such submission, including documentation of how the least burdensome requirements were considered and applied, and documentation of significant controversies or differences of opinion and the resolution thereof.

  • In addition, if this Agreement expires prior to the payment of the Breakthrough Designation Milestone, then Section 2.12 of the Merger Agreement shall survive such expiration.

  • FDA interprets section 517A(a)(2) of the FD&C Act to permit persons who have submitted or who are seeking to submit 510(k)s, PMAs, IDEs, HDEs, or a Breakthrough Designation Request to request substantive summaries of 517A decisions regarding their own device (not the devices of others) without having to file a request under FOIA.

  • For avoidance of doubt, Company is not obligated to achieve the Breakthrough Designation Milestone.

  • In addition, except with respect to the Breakthrough Designation Milestone, if for any reason any other Development Milestone corresponding to a Milestone payment does not occur prior to the occurrence of Regulatory Approval, then such prior non-occurring Development Milestone shall be deemed to occur concurrently with Regulatory Approval, and the applicable Milestone payments for the applicable Development Milestones shall become due and payable in accordance with this Section 8.2.

  • Notwithstanding the foregoing, if the Breakthrough Designation Milestone was not achieved but all other Merger Consideration was paid, then the Term shall expire provided that if Company or its Affiliate or sublicensee ever achieves the Breakthrough Designation Milestone with a subsequent or future Licensed Product, then Parent shall pay the corresponding milestone payment for achievement of the Breakthrough Designation Milestone pursuant to Section 2.12 of the Merger Agreement.

  • For clarity, and notwithstanding the foregoing, following the expiration of the License Agreement, if Company or its Affiliate or sublicensee ever achieves the Breakthrough Designation Milestone with a subsequent or future Licensed Product, then Parent shall pay the corresponding milestone payment for achievement of the Breakthrough Designation Milestone pursuant to this Section 2.12.

  • Brigatinib – a new ALK TKI with Breakthrough Designation from the FDA – is ARIAD’s next cancer medicine in development.

  • Alternative Pathway for Devices That Have a Food and Drug Administration (FDA) Breakthrough Designation For devices that have received FDA marketing authorization and a Breakthrough Device designation from the FDA, CMS provides an alternative pathway to qualify for device pass-through payment status, under which devices would not be evaluated in terms of the current substantial clinical improvement criterion for the purposes of determining device pass-through payment status.

  • The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery.


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 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 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 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).

  • Tyre size designation means a designation showing:

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

  • Step therapy means a protocol or

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • 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.

  • 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;

  • DS Electric generation service that is provided at retail pursuant to the Applicable Legal Authorities under the Company’s retail electric tariffs and under any other agreements or arrangements between the Company and Customers, to any Customer that is not being served by an EGS. Default Allocation Assessment – shall have the meaning ascribed to it under the PJM Agreements. Delivery Period – The delivery period specified in an Appendix C Transaction Confirmation. Delivery Point – Means the applicable zone of the Company as designated by PJM. DS Customer(s) – Retail customers who are provided Default Service pursuant to the terms of this Agreement, the Applicable Legal Authorities and the Company’s retail tariffs.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

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

  • 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 of the Series B Cumulative Convertible Preferred Stock filed with the Secretary of State of the State of Delaware on or prior to the date hereof.

  • 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.

  • SDS means safety data sheet, the written listing of data for the chemical substance.

  • 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;

  • 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.

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