Field Alerts definition

Field Alerts shall have the definition of field alerts used by the FDA irrespective of the jurisdiction in which the acts or circumstances giving rise to such field alerts occur.
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Examples of Field Alerts in a sentence

  • In addition, Savient shall also promptly and fully detail for Enzon any Product complaints or Field Alerts it receives insofar as any such complaints relate to the Services rendered by Enzon hereunder.

  • BVL shall be notified by the Customer of any Field Alerts filed for Product.

  • TransMedics, with data and assistance provided by Fresenius as may be reasonably requested by TransMedics, is responsible for filing Field Alerts.

  • Conor shall be responsible for investigating and documenting all such information relating to Field Alerts.

  • Barrier, with data and assistance provided by DSM, is responsible for filing Field Alerts and initiating product recalls due to any defect considered sufficiently serious.

  • AlgoRx shall be responsible for receiving, investigating, and documenting all such information relating to such Field Alerts.

  • CONTRACT GIVER shall send copies of any Field Alerts and supporting documentation to ACCEPTOR that relate to the manufacturing, processing, packaging or storage of ACCEPTOR product by CONTRACT GIVER.

  • Gen-Probe shall be solely responsible for filing Field Alerts and initiating Product recalls.

  • Manufacturer shall provide copies of Field Alerts (initial and final), Recalls, Medical Assessments and/or follow-up reports to Sharp within [**].

  • In addition, Client shall be solely responsible for (A) taking all actions and conducting all communication with all third parties with respect to all Product Quality Complaints, including complaints related to tampering or contamination, and (B) investigating all Product Quality Complaints, Adverse Events, and Field Alerts with respect to the Product.

Related to Field Alerts

  • API means American Petroleum Institute.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate):

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Hemp products means all products made from industrial hemp,