BLA Submission definition

BLA Submission means an application and all amendments and supplements thereto filed with the Regulatory Authority, including all documents, data, and other information concerning a pharmaceutical product which are necessary for gaining Regulatory Approval to market and sell such pharmaceutical product.
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BLA Submission means submission to the FDA of the Company’s biologics license application with respect to OTL-200 for the treatment of metachromatic leukodystrophy. For clarity, in the event the Company elects to initiate a rolling biologics license application, “BLA Submission” shall be deemed to occur upon the Company’s initial submission of information to the FDA for such purpose.
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BLA Submission is Lenders’ receipt of evidence satisfactory to Lenders that Borrower has submitted the BLA for Borrower’s product candidate, TOCA 511, to the FDA.
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Examples of BLA Submission in a sentence

  • BLA Submission and Amendments SDNReceived3.2 Compliance with Good Clinical Practices (b) (4)Zin-Fil-1501 and ZIN-FIL-1502 GCP compliance statements were reviewed and are adequate.

  • BLA Submission and Review Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications.

  • Kodiak Reboots Tarcocimab Tedromer Development Program Following Strong Positive Results in Phase 3 Diabetic Reti- nopathy GLOW Study and Following Dialogue with US Regulatory Authorities on a Regulatory Pathway for BLA Submission [press release].

  • The press release stated, in relevant part: 7 Corporate Updates89 • Acceptance of BLA Submission for DaxibotulinumtoxinA for Injection (DAXI) in Glabellar Lines Expected Q1 2020 – In November 2019, Revance10 submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for DAXI in the treatment of moderate-to-severe frown11 lines.

  • A promising new approach to carbon nanotube horizontal organization, which has developed rapidly during the last three years, is the growth of carbon nanotubes directed by well-defined crystal surfaces, or “nanotube epitaxy”.

  • Regulatory Matters FDA Refusal to File Letter re HIV BLA Submission In July 2020, the Company received a Refusal to File letter from the FDA regarding its BLA submission for leronlimab as a combination therapy with HAART for highly treatment-experienced HIV patients.

  • Press Release, dated March 16, 2010, titled "Dynavax Anticipates Earlier BLA Submission for HEPLISAV(TM)" SIGNATURES‌ Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  • For comparison, 0.69 percent of Czechs and 0.34 percent of Slovaks moved across the boundaries of administrative regions in 1990.

  • The Hearing Officer must respond to the parent in writing within 7 working days after receipt of the request.

  • Literature Reviewed/ References 49 Table of TablesTable 1: BLA Submission and Amendments.

Related to BLA Submission

  • Regulatory Filing means all applications, filings, submissions, approvals, licenses, registrations, permits, notifications and authorizations (or waivers) with respect to the testing, Development, manufacture or Commercialization of any Licensed Compound or Product made to or received from any Regulatory Authority in a given country, including any INDs and XXXx.

  • Planning Submission or “CAPS” or “Community Accountability Planning Submission” means the HSP Board approved planning document submitted by the HSP to the LHIN. The form, content and scheduling of the Planning Submission will be identified by the LHIN;

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

  • 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.

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • IND means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

  • FDA means the United States Food and Drug Administration.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Electronic Submission means a successful submittal of Offeror’s proposal.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Third-Party Filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.