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.

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

• Decisions to initiate a product recall shall be based on product medical reviews and the investigation report used to support the FDA Field Alert.

• If either Party has information that would require the filing of a 3-day Field Alert report under 21 CFR Section 314.81, that Party shall immediately notify the other Party.

• Drug recalls (NDA/ANDA/NADA/ANADA products) – provide details for any Field Alert submitted HEALTH HAZARD ASSESSMENT: Please provide your assessment of the health risk associated with the deficiency.

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

• The following day, McNeil submitted another Field Alert Report, reporting: As stated in the previous Field Alert Report follow-up issued on March 23, 2009, in order to confirm the availability of Motrin batches SHC003 and SHC004 at the retail level, a statistical sampling of approximately ten (10) percent of all stores across the US that received these batches were visited (250 stores out of 2000).

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 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. 1.28. “Functional Services” means the services set forth in Exhibit C. 1.29. “Governmental Authority” means any federal, state or local court, administrative agency, commission or other governmental authority or instrumentality, including without limitation the FDA, having authority in the United States over the activities contemplated hereunder. Governmental Authority shall include any Regulatory Authority. 1.30. “Intellectual Property Rights” means all intellectual property rights anywhere in the world, whether or not registered, including without limitation patents, utility models, rights in inventions, trademarks, service marks, rights in trade dress (including without limitation product configuration and packaging), rights in business and trade names, rights in domain names, designs, copyrights, trade secrets, rights in Know-How and confidential information, and, in each case, rights of a similar or corresponding character. 1.31. “Joint Management Committee” or “Committee” has the meaning set forth in Section 4. 4

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

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 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 []*.

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.