PLA Submission definition

PLA Submission means the submission to FDA by Xoma of a PLA which has been prepared in good faith by Xoma in a reasonable manner to comply with FDA requirements necessary to obtain Product Approval.
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PLA Submission means a proposal for a PLA that is submitted by a Manufacturer in response to an RFPLA or otherwise.
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Examples of PLA Submission in a sentence

  • 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.

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

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

  • Incremental Direct drug costs to Alberta Health and Wellness sponsored drug programs as a Result of the PLA Terms • Calculate the incremental change in direct prescription costs from Sections 1-9 that the Government-sponsored Drug Plans would incur as a result of the PLA Submission.

  • 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.

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

  • Applicants shall not have any claim for compensation of any kind as a result of participating in this RFPLA’s process, and by submitting a PLA Submission, each Applicant shall be deemed to have waived its right to make a claim.

  • 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.

  • The purpose for collecting Personal Information for this RFPLA is to enable Her Majesty to ensure the accuracy and reliability of the information, to evaluate the PLA Submission, and for other related program purposes of Her Majesty.

  • As an adjunct to the PLA Submission, provide a summary of proposed investment(s) for Health Research Capacity PLAs. Provide the investment by each type of PLA if a hybrid PLA is being presented.