NDA OR BLA definition

NDA OR BLA means either a New Drug Application or Biologics License Application filed with the U.S. Food and Drug Administration to obtain marketing approval for a LICENSED PRODUCT in the United States, or any comparable application filed with regulatory authorities in or for a country or group of countries other than the United States. Yale Confidential
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NDA OR BLA means either a Biologics License Application or New Drug Application filed with the U.S. Food and Drug Administration to obtain marketing approval for a LICENSED PRODUCT in the United States, or any comparable application filed with regulatory authorities in or for a country or group of countries other than the United States.
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NDA OR BLA means an application submitted to the FDA in the United States or the equivalent in any foreign country for marketing approval of a product, including (a) a New Drug Application, Product License Application, or Biologics License Application, and (b) all supplements and amendments that may be filed with respect to the foregoing.
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Examples of NDA OR BLA in a sentence

  • Answer all questions in all sections in relation to the pending application, i.e., if the pending application is an NDA or BLA supplement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA.

  • Orphan drug designation must be requested before submitting an NDA or BLA.

  • Given that a compound as a whole is not approved under an NDA or BLA, a compound does not meet the definition of an applicable drug.

  • Under each of these programs, the sponsor of an NDA or BLA that meets the statutory requirements of the specific program is eligible to receive, upon approval, a transferable voucher, and the sponsor may either use that voucher for the priority review of another application or sell it to another sponsor to use.

  • Under this program, upon the approval of a qualifying NDA or biologics license application, or BLA, for the treatment of a rare pediatric disease, the sponsor of such an application would be eligible for a rare pediatric disease Priority Review Voucher that can be used to obtain priority review for a subsequent NDA or BLA.

  • Even if these data are submitted, the FDA may ultimately decide the NDA or BLA does not satisfy approval criteria.

  • Results of the foregoing are submitted to the FDA as part of a NDA (or BLA in case of biologic products) for marketing and commercial shipment approval.

  • Manufacturing establishments often are inspected prior to NDA or BLA approval to assure compliance with GMPs and with manufacturing commitments made in the application.

  • Once the FDA accepts the NDA or BLA for filing, it begins its in-depth review.

  • The FDA reviews each NDA or BLA submitted and may request additional information.

Related to NDA OR BLA

  • ANDA means an abbreviated new drug application filed with the FDA, pursuant to its rules and regulations (or any equivalent or replacement mechanism).

  • Active Trade or Business means the active conduct (determined in accordance with Section 355(b) of the Code) of the business conducted by the WRECO Group members. For these purposes, members shall include only those members that are part of WRECO’s “separate affiliated group” within the meaning of Section 355(b)(3)(B) of the Code.

  • Combination Product means a product that includes a device for delivery or at least one active ingredient other than a Licensed Product.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Victim or target of Nazi persecution means any individual persecuted or targeted for persecution by

  • Acquired Entity or Business has the meaning specified in the definition of the term “Consolidated EBITDA.”

  • Total organ dose equivalent (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in 641—40.86(1)“f.”

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Exempt compound means the same as defined in Rule 2.

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights granted by a Regulatory Authority (other than Patents) with respect to a Licensed Product sold in a given country, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity or pediatric exclusivity.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • ECB Recommended Rate Index Cessation Effective Date means, in respect of an ECB Recommended Rate Index Cessation Event, the first date on which the ECB Recommended Rate is no longer provided, as determined by the Issuer and notified by the Issuer to the Calculation Agent;

  • Serialization within the part, lot, or batch number means each item of a particular part, lot, or batch number is assigned a unique serial number within that part, lot, or batch number assignment. The enterprise is responsible for ensuring unique serialization within the part, lot, or batch number within the enterprise identifier.

  • Co-licensed partner means a person who, with at least one other person, has the right to engage in