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 A BLA will be submitted to the FDA upon obtaining sufficient clinical data, FDA meetings to support BLA, submission planning support for the CMC team, BLA strategy and meeting support, and submission preparation support activities, will all be completed.

  • January, 2011 Cancer type in development 25 BLA Submission for 2nd Cancer Type Developed 25.

  • Upon receipt of such BLA Submission Notice, Immunomedics shall have sixty days (60) days to exercise the Co-Promotion Option ***.

  • If Immunomedics declines to exercise the Co-Promotion Option within sixty days (60) after receipt of the BLA Submission Notice for ITP, the Co-Promotion Option shall not become exercisable again.

  • January, 2009 type to be developed 22 BLA Submission for Renal Cell Cancer 22.

Related to BLA Submission

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs and NDAs, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

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

  • 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.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).