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.

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.

  • Adverse Drug Experience Reporting Violations and NDA Field Alerts Reporting ViolationsThe charge is as follows:505(k)(1), 21 U.S.C. 355(k)(1) – Your firm failed to establish and maintain records and report data relating to clinical experience, along with other data or information for drugs for which an approved application is in effect, as required by Section 505(k)(1) of the Act, 21 U.S.C. 355(k)(1).

  • The same applies to Recalls with regards to Field Alerts, Customer Complaints and Adverse Events.

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

  • Field Alerts, Biological Product Deviation Reports and Recalls AA.

  • 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.

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) meets 1 or more of the following:

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Alerts means a customized SMS sent to the BO over the said mobile phone number.

  • Hemp products means all products made from industrial hemp,

  • processed products means goods placed under a processing procedure which have undergone processing operations;

  • Manufactured products means items and construction materials composed in whole or in part of non-ferrous metals such as aluminum; plastics and polymer-based products such as polyvinyl chloride pipe; aggregates such as concrete; glass, including optical fiber; and lumber.

  • Cost of materials means the cost of components, parts or materials which are intended for the production, manufacturing or assembling of the goods bid for and which are not produced, manufactured or assembled in the factory where the production, manufacture or assembly of such goods occurs, including freight, landing costs, port charges, import duties and other import costs of such components, parts or materials and all costs in connection with the handling and transport thereof prior to delivery at that factory;

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Product Know-How means Know-How

  • Manufacturing Process means any process for—

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Manufacturer means the person or body responsible to the approval authority for all aspects of the type approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stages of the construction of the vehicle which is the subject of the approval process.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • APIs means SAP application programming interface and accompanying or related Documentation, source code, tools, executable applications, libraries, subroutines, widgets and other materials made available by SAP or through SAP tools or SAP Software Development Kit (and all derivative works or modifications thereof) to Provider that allow Provider to integrate the Provider Service with the Cloud Service, including any access code, authentication keys or similar mechanisms to enable access of the APIs.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • EXXXX means the Commission’s Electronic Data Gathering, Analysis and Retrieval System.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • DSM means the most current edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association.

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.