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.
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Field Alert is defined in Section 9.1.9.
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Examples of Field Alert in a sentence

  • The manufacturer of a drug subject to an approved new drug application was required to notify FDA in a "Field Alert Report" within three working days of receiving information if the information concerned any bacteriological contamination, or any significant chemical, physical or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it under the drug's approved new drug application.

  • CONTRACT GIVER shall notify ACCEPTOR within two (2) business day of being aware that there might be a concern with the Product and if any batch of Product could be subject to a "Field Alert." The CONTRACT GIVER shall be the responsible party for any XXXXXX Chinese FDA contacts and for filing any Field Alerts and/or any follow up reports.

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

  • If assessment by the CONTRACT GIVER results in a Field Alert requirement, the CONTRACT GIVER will file a Field Alert in accordance with 21CFR314.81.

  • Horizon shall consult with sanofi-aventis regarding any Recall or Field Alert that may be due to manufacture; provided, however, that Horizon shall retain sole discretion whether to institute a Recall.


More Definitions of Field Alert

Field Alert has the meaning ascribed to such term in Section 9.1(e).
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Field Alert means an “NDA Field Alert Report” pursuant to 21 CFR 314.81(b)(1) resulting from an incident that causes Product or its labeling to be mistaken for or applied to another article, bacterial contamination, a significant chemical, physical, or other change, deterioration in distributed Product, or failure of one or more distributed Batches of finished Product to meet the specifications established for it in the application for Regulatory Approval.
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Field Alert. Notification of a potential safety threat for drug products in commercial distribution within the United States, which are marketed under an approved NDA or ANDA, as defined by FDA in 21CFR 314.81 (b)(1) (i) and (ii).
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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).
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Field Alert has the meaning set forth in Section 4.9.
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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 []*.
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Field Alert has the meaning set forth in Section 6.2 of this Agreement.
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