Alert Report definition

Alert Report is the report per FDA 21 CFR 314.80 Reporting Requirements for postmarketing 15-day “Alert” reports; these are adverse drug experience reports that are both serious and unexpected, and must be reported in writing to the FDA within 15 calendar days.
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Examples of Alert Report in a sentence

  • Customer is responsible for notifying the FDA regarding any required Field Alert Report according to 21 CFR 314.81.

  • ProDUR Alert Report Quarterly report highlighting prospective alerts and responses for pharmacy claims.

  • Schein will advise Miles of NDA Field Alert Report submission and forward a copy of any such report to the Complaint Coordinator (see A.1 above) of Miles.

  • PRODUCT issues arising from stability data or other manufacturing issues that meet Field Alert Report criteria will be communicated by Fresenius to TransMedics in writing within five (5) business days.

  • Complaint reports which may meet NDA-Field Alert Report Criteria t21 CFR 314.81 (b) (1)] will be promptly communicated to Schein enabling FDA notification by Schein within three working days.

  • Distributor shall notify Manufacturer of any Adverse Drug Experience and/or Field Alert Report Events with respect to a Product within *** (***) *** of the time such Adverse Drug Experience or Field Alert Report Events becomes known to Distributor or its employees or any of their Affiliates and such reports shall be made in accordance with and in the manner set forth on the form attached hereto as Exhibit 7.1.

  • ELITE shall notify PRECISION DOSE immediately of any failure that meets Field Alert Report criteria.

  • Medtronic shall be responsible for coordinating all the necessary activities in connection with such recall, product withdrawal or Field Alert Report, the costs of which shall be reimbursed by UT in accordance with Section 3.9, Section 6.2 and the applicable Budget.

  • Tercica is responsible for notifying the FDA regarding any required Field Alert Report according to 21 CFR 314.81.

  • Medtronic shall have the responsibility and sole authority for making the final decision on whether to initiate a recall, a product withdrawal or Field Alert Report for the ISR, Accessories, and System.

Related to Alert Report

  • 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;

  • MI Report means a report containing Management Information submitted to the Authority in accordance with Framework Schedule 9 (Management Information);

  • ESDM Report means the Emission Summary and Dispersion Modelling Report prepared in accordance with the Procedure Document by Canadian ORTECH Environmental Inc. and dated March 26, 2004 submitted in support of the application, and includes any amendments to the ESDM Report listed in Schedule A, and all up-dated ESDM Reports prepared as required by the Documentation Requirements conditions of this Certificate.

  • Rapidly report means within 72 hours of discovery of any cyber incident.

  • Cost Report means a report detailing all costs incurred in relation to the Activity, to be submitted by the Incubatee to the Incubator.