Field Alert definition

Field Alert means a field alert report, as required under 21 C.F.R. § 314.81(b)(1), as such regulation may be amended from time to time.

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Field Alert has the meaning set forth in Section 2.14(b) of this Agreement.

Field Alert is defined in Section 9.1.9.

Examples of Field Alert in a sentence

• For clarification, in the event ▇▇▇▇▇▇▇▇ becomes aware of a Product Quality Complaint, Adverse Event, Other Reportable Information, Field Alert, or other compliance inquiry or investigation with respect to the Product, EVERSANA is only responsible for informing the Third Party that information in respect thereof has been or will be conveyed by ▇▇▇▇▇▇▇▇ to Client.

• EVERSANA shall cooperate with Client’s reasonable requests and assist Client in connection with Client’s: (i) preparing any and all reports to FDA concerning the Product; (ii) preparing and disseminating all communications to Third Parties concerning the Product; and (iii) investigating and responding to any Product Quality Complaint, Adverse Event, Other Reportable Information, Field Alert, or other compliance inquiry or investigation related to the Product.

• As between the Parties, Client has the sole responsibility for (i) any statements, whether written or oral, to a Third Party regarding a Product Quality Complaint, Adverse Event, Other Reportable Information, Field Alert, or other compliance inquiry or investigation with respect to the Product, and (ii) taking any action concerning any Regulatory Authority approval under which the Product is sold.

More Definitions of Field Alert

Field Alert has the meaning ascribed to such term in Section 8.1.

Field Alert. Notification of a potential safety threat for drug products in commercial distribution within the United States, which are marketed under an approved marketing application, as defined by FDA in 21CFR 314.81 (b)(1).

Field Alert means any field alert report submitted or required to be submitted to the FDA to identify quality defects in any Product pursuant to 21 CFR 314.81(b)(1).

Field Alert means a field alert report, as required under 21 C.F.R. § 314.81(b)(1), as such regulation may be amended from time to time. 1.52 “Field Force” means the Dedicated and non-Dedicated Employees deployed in the Territory in customer-facing roles to render the Services hereunder, including, but not limited to, the Sales Force, medical science liaisons, other medical field team members, account and trade team members, nurse educators, and medical information call center personnel. 1.53 “GAAP” means United States generally accepted accounting principles. 1.54 “Government Official” shall mean (a) any elected or appointed government official (e.g., a member of a ministry of health); (b) any employee or person acting for or on behalf of a government, government-controlled entity or enterprise performing a governmental function; (c) any political party, candidate for public office, officer, employee, or person acting for or on behalf of a political party or candidate for public office; (d) any employee

Field Alert has the meaning set forth in Section 6.2 of this Agreement.

Field Alert means a field alert report, as required under 21 C.F.R. § 314.81(b)(1), as such regulation may be amended from time to time.

Field Alert has the meaning ascribed to such term in Section 8.1(i). (fff) []* has the meaning ascribed to such term in Exhibit A. (ggg) []* means, with respect to any period, Net Sales for such period, less []*.