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.

  • 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.

  • We have designed a development plan for our Hemopurifier focused on oncology indications, improved the manufacturing process, established quality systems, had multiple interactions with the FDA under our Breakthrough Designation, including a face to face meeting in Bethesda, Maryland in June and prepared for an Investigational Device Exemption (IDE) application to initiate clinical trials in cancer.

  • Based on these observations and data, in November 2019 the FDA granted us a second Breakthrough Designation “…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease.” In June 2019, we met with the FDA in Bethesda, Maryland to discuss the development program for the Hemopurifier in cancer.

  • 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.

  • 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 provided 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 Breakthrough Designation status results in expedited review by the agency.

  • In addition, the FDA granted the compound its Breakthrough Designation, indicating the drug is (1) intended to treat a serious or life-threatening disease or condition alone or combined with one or more other drugs, and (2) preliminary clinical evidence indicates it may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

  • Breakthrough Designation was granted on December 14, 2017, based on the topline results of Study D2311.

  • Alternative Pathway for Devices That Have a FDA Breakthrough Designation For devices that have received FDA marketing authorization and a Breakthrough Device designation from the FDA, CMS provided 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.


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 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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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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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 protocol or

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

  • 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

  • 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(e).

  • 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;

  • Cardiopulmonary resuscitation or "CPR" means artificial ventilation or external

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

  • 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.

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

  • Moving beam radiation therapy means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

  • Series B Certificate of Designation means the Certificate of Designation of the Powers, Preferences and Relative, Participating, Optional and Other Special Rights of 8% Series B Convertible Redeemable Preferred Stock and Qualifications, Limitations and Restrictions Thereof.

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

  • Series B Certificate of Designations has the meaning set forth in the recitals hereto.

  • 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 or "PPO" means an entity through which a group of health care providers, such as doctors, hospitals and others, agree to provide specific medical and hospital care and some related services at a negotiated price.

  • Investment Strategy Modification means with respect to an Investment Strategy, the Portfolio Administrator makes operational adjustments to the Investment Strategy to ensure that, so far as possible, the basic principles and economic effect of the Investment Strategy are maintained or any material modification to the Investment Strategy or its implementation by the Portfolio Administrator.

  • Stationary beam radiation therapy means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.