PLA submission definition

PLA submission means the submission to the FDA by the Company or its sublicensee of a PLA that has been prepared in good faith by the Company or its sublicensee to comply with FDA requirements necessary to obtain Product Approval.
Sample 1
PLA submission means a proposal for a PLA that is submitted by a Manufacturer in response to an RFPLA or otherwise.
Sample 1Sample 2

Examples of PLA submission in a sentence

  • Failure to do so may result in the PLA Submission being deemed incomplete and/or delays in potential listing decisions.

  • However, thus far, no agreement has been reached on how the associated costs of upgrading the Coos Loop would be shared among parties.

  • Referencing the conclusions of the budget impact assessment and the overall proposed cost impact to the Alberta Health and Wellness sponsored drug programs summarize the PLA Submission identifying how the value of the PLA offsets the impact to the AHWDBL budget and identifying the key terms being offered to AHW and the terms being required of AHW.

  • The PLA Submission Form in Appendix B of this RFPLA, must be completed, and included in the PLA Submission.

  • Failure to satisfy any term, condition or mandatory requirement of the RFPLA submission requirements may result in rejection of the PLA Submission.

  • Failure to provide a response to requirements described with a “mandatory” may result in rejection of the PLA Submission.

  • The mandatory and desirable requirements in this RFPLA will be utilized in evaluating each PLA Submission.

  • The Applicant is responsible for all costs of preparing and presenting its PLA Submission and, if applicable, Contract finalization.

  • A PLA submission must include the information required by the PLA Submission Form and this RFPLA as well as details of therapeutic advantage, therapeutic equivalency, cost effectiveness and/or cost savings that the subject drug may provide.

  • If the Applicant does not accept the Contractual Terms and Conditions provisions exactly as drafted, the Applicant must expressly indicate in its PLA Submission that it does not accept the Terms and Conditions provisions and provide the Applicant’s final position on the provision i.e. the wording that the Applicant requires for the Applicant to enter into a contract.

Related to PLA 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.

  • 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;

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • 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.

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

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

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

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

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

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

  • 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.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • 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.

  • JDC has the meaning set forth in Section 3.2.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • IND means an investigational new drug application filed with the FDA with respect to a Product, or an equivalent application filed with a Regulatory Authority in a country other than the United States to commence a clinical trial of pharmaceutical product.

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

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

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

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • 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.

  • Submission Location means the submission location identified as such in the Summary of Key Information.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.