Biological License Application definition

Biological License Application or “BLA” means a Biological License Application in the United States as described in Section 351(a) of the United States Public Health Service Act (PHS Act), or an abbreviated Biological License Application as described in Section 351(k) of the PHS Act.
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Biological License Application or "BLA" shall mean Biological ------------------------------ --- License Application as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and any corresponding foreign application, registration or certification.
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Biological License Application or "BLA" shall mean the Japanese equivalent of a Biological License Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and any corresponding foreign application, registration or certification in the Territory.
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Examples of Biological License Application in a sentence

  • In some cases, representatives from the collaborating company may participate on the protocol as Associate Investigators or Medical Monitors for purposes of gathering information for New Drug Applications or a Biological License Application with the FDA.

  • The goal of this project is to develop an efficacious hybridoma-based idiotype vaccine to produce long-term disease-free survival in follicular B-cell lymphoma patients who have attained a complete clinical response from chemotherapy and to compile data required to support a Biological License Application (BLA) to the U.S. Food and Drug Administration (FDA) for hybridoma-based idiotype follicular B-cell lymphoma vaccine.

  • We plan to utilize the robust dataset for OK-432 in LMs to support the potential filing of a Biological License Application (BLA) for TARA-002 in lymphatic LMs. We are encouraged by the progress to date and, at the FDA’s request, have submitted the full Clinical Study Report (CSR) of the randomized Phase 2 study of OK-432 in LMs led by the University of Iowa.

  • Miltenyi shall in no way be held responsible for any refusal by any Regulatory Authority or ethics committee to grant permission to conduct a clinical trial(s) and/or for any refusal by any Regulatory Authority to grant approval under an Investigational New Drug Application (IND) or under a Biological License Application (BLA) or for compassionate use for a Autolus Product.

  • The Corporation also continues to be in licensing discussions with potential partners as it also continues to work towards refiling its Biological License Application (“BLA”) of its most advanced product, RyplazimTM.

  • Records - In the US, federal regulations require that copies of case report forms be retained by the Investigator for a period of no less than two (2) years following either the approval of Biological License Application or the withdrawal of the Investigational New Drug Application.

  • Failure for Company to achieve the specific Diligence Requirement under Section 3.1(f) shall not result in termination of this Agreement, but such failure shall restrict Company’s License Territory to the specific Major Market Country for which it has filed for a Biological License Application pursuant to the Diligence Requirement under Section 3.1 (e).

  • With respect to any CLINICAL PRODUCT for which any MILESTONE PAYMENT has been made, LICENSEE and any SUB-LICENSEE shall have no obligation to make the same MILESTONE PAYMENT when and if such party makes any filing (including amendments to the applicable Biological License Application) or obtains any approvals related to the use of the same CLINICAL PRODUCT for indications additional to the indication for which the first MILESTONE PAYMENT(S) for such CLINICAL PRODUCT was (were) made.

  • The Parties shall fully cooperate in good faith, and shall provide all reasonable assistance and information, in a timely manner, to each other, to obtain and maintain all Regulatory Approvals that are required to manufacture, distribute, use or sell the Products, including without limitation the preparation, filing and maintenance of any U.S. Biological License Application or European Marketing Authorization (or equivalent in other jurisdictions).

  • For projects pertaining to Area 1, applicants are expected to propose activities that will lead to the successful filing of an Investigational New Drug (IND) application, as well as clinical studies to support the filing of a New Drug Application (NDA) and/or Biological License Application (BLA).


More Definitions of Biological License Application

Biological License Application or “BLA” means a Biological License Application as described in Section 351(a) of the Public Health Service Act (PHS Act), or an abbreviated Biological License Application as described in Section 351(k) of the PHS Act (an “aBLA”), in each case in the Territory.
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Related to Biological License Application

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • FDCA shall have the meaning ascribed to such term in Section 3.1(hh).

  • ANDA means Abbreviated New Drug Application.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • NDA means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification.

  • Cancer drug means a prescription drug used to treat:

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • FD&C Act means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.

  • Therapeutic school means a residential group living facility:

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