Prescribing Information definition

Prescribing Information means the FDA-approved labeling for the Product.

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Prescribing Information means the prescribing information published by Wyeth in connection with the Marketing of the Product.

Prescribing Information means the then-current, FDA-approved summary of the information needed for safe and effective use of the Ziftomenib Product.

Examples of Prescribing Information in a sentence

The requirement does not apply to prescriptions for (a) solid oral doses of antibiotics; or (b) solid oral doses that are dispensed in their original container as indicated in the federal Food and Drug Administration Prescribing Information or (c) are customarily dispensed in their original packaging.
Products must be administered under the direction of a physician or other healthcare professional authorized by applicable state law, in accordance with the Prescribing Information, Instructions for Use and Customer’s applicable provincial medical regulations.
Please see last page and full Prescribing Information and Patient Information for important safety information.
Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at ▇▇▇.▇▇▇▇▇▇▇▇▇▇-▇▇.▇▇▇.
Additionally, Preferred Products shall not be subject to clinical edits, prior authorization, step therapy or similar utilization management controls that are more restrictive than the FDA-approved Prescribing Information as of the Effective Date of this Agreement, except that the Department may also apply other clinical edits, prior authorization, step therapy or similar utilization management controls equally to all products in a therapeutic class.
The requirement does not apply to prescriptions for (a) solid oral doses of antibiotics; or (b) solid oral doses that are dispensed in their original container as indicated in the federal Food and Drug Administration Prescribing Information or are customarily dispensed in their original packaging to assist a patient with compliance.
No less than ten (10) days prior to planned submission to the FDA, Valera shall provide Indevus with drafts of submissions that are intended to change or modify the Product Label, FDA-Approved Prescribing Information for, or the indications of, any Product, or any Promotional Materials.
See also the Prescribing Information for pemetrexed and carboplatin.
In connection with the provision of Services, ESSDS shall at all times handle, maintain, store, transport and deliver the Product in accordance with all Applicable Laws and SOPs. ESSDS will prepare the Product under conditions that are consistent with currently accepted standards of care including relevant requirements specified in the applicable SOPs and Work Instructions, the REMS Program, and Product Prescribing Information.
AstraZeneca will use reasonable efforts to effect a change to the Prescribing Information that reflects either prolongation of symptom control and/or extended use of the Product in a long-term therapy setting.

More Definitions of Prescribing Information

Prescribing Information means the FDA-approved labeling for the Product. 1.52. “Product” means Qtrypta (zolmitriptan intracutaneous microneedle system). 1.53. “Product Copyrights” means all copyrightable subject matter related to the Product included in the Prescribing Information, the Promotional Materials, training materials or other material provided hereunder or otherwise authorized or approved by Zosano under this Agreement for use by Eversana in performing the Services. 1.54. “Product Quality Complaint” means any and all manufacturing or packaging-related complaints related to the Product, including without limitation (a) any complaint involving the possible failure of the Product to meet any of the specifications for the Product and (b) any dissatisfaction with the design, package or labeling of the Product. 1.55. “Product Trademarks” means the trademarks used for the Product that are controlled by Zosano during the Term in the Territory, including without limitation any such trademarks for the Product used in the Prescribing Information, Promotional Materials, training materials or other material provided hereunder or otherwise authorized or approved by Zosano, excluding the Corporate Trademarks. 1.56. “Regulatory Authority” means any national, federal, state, or local governmental or regulatory authority, agency, department, bureau, commission, council or other government entity located in the Territory, including without limitation FDA, Centers for Medicare and Medicaid Services (CMS), and the Office of Inspector General of the U.S. Department of Health and Human Services, regulating or otherwise (a) exercising authority with respect to the development, manufacture, approval, registrations, licensing, or commercialization of the Product in such regulatory jurisdiction in the Territory, or (b) having legal authority with respect to the exploitation of the Product in the Territory. 1.57. “Regulatory Documentation” means all applications, registrations, licenses, authorizations and approvals, all correspondence submitted to or received from Regulatory Authorities (including without limitation minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, relating to the Product, and all data contained in any of the foregoing, including without limitation all Regulatory Authority approvals, regulatory drug lists, advertising and promotion documents and related FDA submission...

Prescribing Information means the FDA-approved labeling for the Product. 1.91 “Post-Approval Period" means from the BLA Date through the end of the Term. 1.92 “Pre-Approval Period” means the period between the Effective Date and the BLA Date. 1.93 “Pre-Approval Services” means the services set forth in Exhibit B to be performed by ▇▇▇▇▇▇▇▇ before the BLA Approval Date, as the same may be amended, modified or supplemented from time to time in accordance with Section 3.3. 1.94 “Pre-Approval Service Fees” means the fees actually incurred by EVERSANA to perform the Pre-Approval Services according to the fee estimate and the fee structure set forth in Exhibit B, as the same may be amended, modified or supplemented from time to time in accordance with Section 3.3. 1.95 “Prior CDA” means that certain Mutual Confidential Disclosure Agreement between the Parties dated [***]. 1.96 “Product” means PRGN-2012. 1.97 “Product Copyrights” means all copyrightable subject matter related to the Product included in the Prescribing Information, the Promotional Materials, training materials related to the Product or other Product-related material provided hereunder or otherwise authorized or approved by Client under this Agreement for use by EVERSANA in performing the Services. 1.98 “Product Quality Complaint” means any and all manufacturing or packaging-related complaints related to the Product, including (a) any complaint involving the possible failure of the Product to meet any of the specifications for the Product and (b) any dissatisfaction with the design, packaging or labeling of the Product. 1.99 “Product Trademarks” means the Product-specific trademarks owned or Controlled by Client during the Term in the Territory, including any such Product-specific trademarks (a) used in the Prescribing Information or (b) authorized or approved by Client for use in Promotional Materials, training materials regarding the Product, or other material relating to the Product that may be provided or generated hereunder; but, in each case, excluding the Corporate Trademarks. 1.100 “Product Training” means the Product-specific training program for Key Account Directors and Medical Science Liaisons conducted in accordance with the