Alert Reports definition

Alert Reports means reports provided to the Customer by the Sure Portal.
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Examples of Alert Reports in a sentence

  • This includes individual case 15-Day Alert Reports and Periodic Safety Reports or Periodic Safety Update Reports, if applicable.

  • All drug manufacturers with approved New Drug Applications or Biological License Applications are required to submit Field Alert Reports or Biological Product Deviation Reports, respectively, to the FDA if they find any significant problems with an approved drug (ref.: 21 CFR 314.81 or 600.14).

  • This includes ​ ​ individual case [****] -Day Alert Reports and Periodic Safety Reports or Periodic Safety Update Reports, if applicable.

  • Copies of any Drug Adverse Reaction Experience Reports and NDA Field Alert Reports or foreign equivalents shall be promptly forwarded to PFC by Baxter, except that when PFC in its capacity as a licensor of the Product under this arrangement with Baxter receives such reports in the first instance, it shall forward the same promptly to Baxter.

  • Within ten (10) business days after submission, Spectrum shall provide ▇▇▇▇▇▇▇ with copies of all fifteen (15) day "Alert Reports" submitted to the FDA that relate to a Product.

  • Within five (5) days of submission, ViroPharma shall provide Aventis with a copy of any 15 day "Alert Reports" relating to any VP Product submitted to FDA in accordance with 21 C.F.R. (S) 314.80(c)(1) and any periodic adverse drug experience report relating to any VP Product submitted in accordance with 21 C.F.R. (S) 314.80(c)(2).

  • Copies of any Drug Adverse Reaction Experience Reports and NDA Field Alert Reports or foreign equivalents shall be promptly forwarded to PFC by Alliance, except that when PFC in its capacity as a licensor of the Product under this arrangement with Alliance receives such reports in the first instance, it shall forward the same promptly to Alliance.

  • USB will provide ALZA with copies of all 15 Day Alert Reports submitted to the FDA within 48 hours of submission.

  • INSTITUTION and PRINCIPAL INVESTIGATOR further agree to report adverse events, including Expedited Alert Reports to LIXTE and to relevant regulatory agencies, in compliance with all applicable legal and regulatory requirements and in fulfillment of the requisite duties and obligations in conducting the STUDY.

Related to Alert Reports

  • SOS Reports means the official reports from the Secretaries of State of each Collateral State, Chief Executive Office State and the Borrower State and other applicable federal, state or local government offices identifying all current security interests filed in the Collateral and Liens of record as of the date of such report.

  • Reports means the reports described in Schedule B as well as any other reports or information required to be provided under the Enabling Legislation or this Agreement;

  • Parent Reports has the meaning set forth in Section 4.5(a).

  • Progress Reports The Progress Reports as required by the individual Task Work Orders issued pursuant to this Agreement. Responsible: Responsible or Responsibility means the financial ability, legal capacity, integrity and past performance of Contractor and as such terms have been interpreted relative to public procurements. See NYS Finance Law § 163(1)(c).

  • GLJ Report means the independent engineering reserves evaluation of certain oil, NGL and natural gas interests of the Company prepared by GLJ dated February 8, 2016 and effective December 31, 2015;