PLA submission definition

PLA submission means the submission to the FDA by Funder of a PLA which has been prepared in good faith by Funder in a reasonable manner 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

  • Please note that a course description does not provide adequate information for assessment and will NOT be accepted for PLA submission.

  • The Minister may, in the Minister’s sole discretion, issue an RFPLA to invite certain or all Manufacturers to make a PLA submission for the consideration of the Minister.

  • In the event that negotiations with the manufacturer appear to be not progressing, or potentially protracted, at the Minister’s sole discretion the PLA submission may be deemed to be of no effect.

  • 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 for any reason AHW and the Manufacturer do not finalize a PLA within the timetable established, the PLA submission shall be deemed to be of no effect, unless the Minister, in the Minister’s sole discretion, extends the timeframe.

  • PLA submission fees, educational supplies, living expenses, physical textbooks and other fees not listed are not included.5. Whether or not currently enrolled, tuition reimbursement received from other source(s) including but not limited to corporate reimbursement, other scholarships and/or private grants may reduce a recipient’s eligibility dollar for dollar unless the funder specifies the funds may be released to the student.

  • For greater clarity: A PLA submission for an Utilization Management Agreement must:• outline the planned methodology for utilization management in detail;• explain the environment required to conduct the UMA including:o availability, accessibility and complexity of accessing of personnel, facilities and infrastructure required to execute, implement and perform the UMA.

  • PLA submission fees, educational supplies, living expenses, physical textbooks and other fees not listed are not included.

  • So how can you exercise a PLA and also submit RDT without having the resource IDs?A correction has been made to make thesubmission of the RDT concurrent with the PLA submission.

  • In the case where a PLA submission is made for a drug that is not currently listed on the AHWDBL, the drug will not be added to the AHWDBL until the PLA has been executed by all parties.

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 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 LHIN. The form, content and scheduling of the Planning Submission will be identified by the LHIN;

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • 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 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).

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • 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.

  • FDA means the United States Food and Drug Administration.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • 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 (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.

  • 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 any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • 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.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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.

  • 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.