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.
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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...
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Examples of Prescribing Information in a sentence

  • The applicant’s proposed PI was reviewed in accordance with the labeling format requirements listed in the “Selected Requirements for Prescribing Information (SRPI)” checklist (see the Appendix).

  • For information about submitting promotional materials, see the final guidance for industry Providing Regulatory Submissions in Electronic and Non- Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs.3 You must submit final promotional materials and Prescribing Information, accompanied by a Form FDA 2253, at the time of initial dissemination or publication[21 CFR 314.81(b)(3)(i)].

  • To do so, submit the following, in triplicate, (1) a cover letter requesting advisory comments, (2) the proposed materials in draft or mock-up form with annotated references, and (3) the Prescribing Information to: OPDP Regulatory Project Manager Food and Drug AdministrationCenter for Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP) 5901-B Ammendale RoadBeltsville, MD 20705-1266 Alternatively, you may submit a request for advisory comments electronically in eCTD format.

  • The applicant’s proposed PI was reviewed in accordance with the labeling format requirements listed in the “Selected Requirements of Prescribing Information (SRPI)” checklist (see Section 4 of this review).

  • The applicant may employ a basic or comprehensive approach to the TPP.Many companies use the US Prescribing Information format to create the TPP: https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources.

  • 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.

  • Projections indicate that by 2060, the total installed capacity of electrolysers in China will reach 500 GW, with 80% of hydrogen demand met through ReP2H [1] [2].The scaled ReP2H integrated into the power system can be classified into grid-connected and off-grid types.

  • A horizontal line must separate: HL from the Table of Contents (TOC), and TOC from the Full Prescribing Information (FPI).Comment:4.

  • Highlights of Prescribing Information: Genotropin (somatropin [rDNA origin] for injection).

  • Highlights of Prescribing Information: Spinraza (nusinersen) injection, for intrathecal use: Prescribing label.

Related to Prescribing Information

  • Staffing Information in relation to all persons identified on the Supplier's Provisional Supplier Personnel List or Supplier's Final Supplier Personnel List, as the case may be, such information as the Department may reasonably request (subject to all applicable provisions of the DPA), but including in an anonymised format: (a) their ages, dates of commencement of employment or engagement, gender and place of work; (b) details of whether they are employed, self employed contractors or consultants, agency workers or otherwise; (c) the identity of the employer or relevant contracting Party; (d) their relevant contractual notice periods and any other terms relating to termination of employment, including redundancy procedures, and redundancy payments; (e) their wages, salaries, bonuses and profit sharing arrangements as applicable; (f) details of other employment-related benefits, including (without limitation) medical insurance, life assurance, pension or other retirement benefit schemes, share option schemes and company car schedules applicable to them; (g) any outstanding or potential contractual, statutory or other liabilities in respect of such individuals (including in respect of personal injury claims); (h) details of any such individuals on long term sickness absence, parental leave, maternity leave or other authorised long term absence; (i) copies of all relevant documents and materials relating to such information, including copies of relevant Agreements of employment (or relevant standard Agreements if applied generally in respect of such employees); and (j) any other “employee liability information” as such term is defined in regulation 11 of the Employment Regulations;

  • Identifying information means the same as that term is defined in § 18.2-186.3, and

  • Billing information means any data that enables any person to access a customer’s or donor’s account, such as a credit card, checking, savings, share or similar account, utility bill, mort- gage loan account, or debit card.

  • Benchmarking Information means information generated by Portfolio Manager, as herein defined including descriptive information about the physical building and its operational characteristics.

  • User Information means User Compliance Information and User Financial Information.

  • Program Information has the meaning set forth in Section 14.8.

  • Marketing Information means marketing studies, marketing analyses, and similar research and information designed to identify potential customers and business relationships.

  • Appendix Information means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in:

  • Patient identifying information means an insured's address, telephone number, facsimile number, electronic mail address, photograph or likeness, employer, employment status, social security number, or any other information that is likely to lead to the identification of the insured.

  • Information has the meaning specified in Section 10.07.

  • Supporting information means the experience and judgment of the filer and the experience or data of other insurers or organizations relied on by the filer, the interpretation of any statistical data relied on by the filer, description or methods used in making the rates and any other similar information required to be filed by the commissioner.

  • Pricing Information means the information relating to (i) the number of Shares issued and (ii) the offering price of the Shares included on the cover page of the Prospectus.

  • Listing Information means an Onvoy Customer’s primary name, address (including city, state and zip code), telephone number(s), the delivery address and number of directories to be delivered, and, in the case of a business Customer, the primary business heading under which the business Customer desires to be placed, and any other information Frontier deems necessary for the publication and delivery of directories.

  • Financing Information means (i) audited consolidated balance sheets and related statements of income, comprehensive income and cash flows of the Company and its Subsidiaries for the three most recently completed fiscal years ended at least 60 days prior to the Closing Date; (ii) unaudited interim consolidated balance sheets and related statements of income, comprehensive income and cash flows of the Company and its Subsidiaries for the fiscal quarter ended at least 60 days prior to the Closing Date (but excluding the fourth quarter of any fiscal year); and (iii) all other information regarding the Company and its Subsidiaries required by Regulation S-X and Regulation S-K under the Securities Act for an offering of securities of Parent on a registration statement filed with the SEC, in each case, of the type that would permit the Company’s independent auditors to deliver customary “comfort” (including customary “negative assurance” comfort) in connection with such offering which such auditors are prepared to provide upon completion of customary procedures.

  • voting information means postal voting information and/or e-voting information 1.2 Other expressions used in these rules and in Schedule 7 to the NHS Act 2006 have the same meaning in these rules as in that Schedule.

  • Accounting Information means (a) the annual audited consolidated financial statements of the Group and (b) the quarterly unaudited consolidated financial statements of the Group, each as provided or (as the context may require) to be provided to the Bank in accordance with clause 5.1.4;

  • Derived Information means such written information regarding the Notes as is disseminated by any Underwriter to a potential investor, which information is not any of (A) Issuer Information, (B) Prepricing Information or (C) contained in the Registration Statement, the Preliminary Prospectus, the Ratings Free Writing Prospectus or the Prospectus or any amendment or supplement to any of them, taking into account information incorporated therein by reference (other than information incorporated by reference from any information regarding the Notes that is disseminated by any Underwriter to a potential investor); and

  • Member Information means the share, deposit, loan account balances, or other information related to any member of a domestic credit union maintained in any form.

  • Keeping information confidential means using discretion in disclosing information as well as guarding against unlawful or inappropriate access by others. This includes:

  • Confidential commercial information means records provided to the govern- ment by a submitter that arguably contain material exempt from release under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), be- cause disclosure could reasonably be expected to cause substantial competi- tive harm.

  • Commercial Information means information regarding the purchase and sale of goods and services, including, but not limited to, information regarding marketing strategy, production data, assessments of goods and services, mineral exploration records, and compilations of data regarding commercial activity.

  • Restricting Information has the meaning specified in Section 10.09(a).

  • Medical information means any information about a consumer's medical or mental health treatment or diagnosis by a health care professional.

  • Product Information has the meaning specified in Section 10.12(a).

  • Personal Identifying Information or “PII” means information that alone, or in conjunction with other information, identifies an individual, as defined at Tex. Bus. & Com. Code § 521.002(1).

  • Cardholder Information means any non-public, sensitive information about a Cardholder, including any combination of Cardholder name plus the Cardholder’s social security number, driver’s license or other identification number or credit or debit card number, or other bank account number.