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

  • This committee has been empowered to inspect the potential places for ragging.

  • Our timeline for submission of our Biological License Application (BLA) for StaphVAX with the FDA in the U.S. is unchanged.

  • 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.

  • As opposed to the NDA process, marketing of biologics requires FDA approval of a Biological License Application (BLA), which pertains to both the biologic product itself and the producing facility.

  • 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.

  • 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.

  • While the facility is approved by the FDA under the Biological License Application (“BLA”) for Alferon®, this status will need to be reaffirmed by an FDA pre-approval inspection.

  • Hospitalized individuals generally need to be motivated or encouraged to eat.

  • The selected sponsor will collaborate in the development and production of GMP certifiable idiotype vaccines for the treatment of follicular B-cell lymphomas to be used in the Phase III clinical trials leading to a New Drug Application or Biological License Application for a new anti-cancer therapy in anticipation of the successful commercialization of this product.

  • The enormous opportunity aheadJayride is now positioned to leverage its network effects and scale into its new global foundations, to achieve true and lasting success as a profitable, global leader in transport and travel technology.


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 of a Licensed Product as a pharmaceutical product in a country in the Territory.

  • FDA means the United States Food and Drug Administration.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • 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 In Vitro Diagnostics, In Vivo Diagnostic Agents and any other aptamer product used for Diagnosis. For purposes of clarity, the term Diagnostic Product shall not include a product used for the delay of onset or progression of, or treatment or prevention of, an Indication.

  • 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.

  • 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 an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • 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 regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • 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.

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • 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 may be amended from time to time.

  • Therapeutic school means a residential group living facility:

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