Safety Issue definition

Safety Issue means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for the BMS Study Drug, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.

Safety Issue means any unexpected or untoward adverse event related to a Product that is reported to a Party by a patient or physician, or about which a Party becomes aware, which event raises a question about patient safety or the efficacy of such Product and which event a Party considers to be serious enough to contemplate taking a prompt affirmative action with respect to such Product.

Safety Issue means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for a drug, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.

Examples of Safety Issue in a sentence

• Your Safety Complaints and Safety Complaints of others TO NHTSA may conduct a Safety Investigation OR Manufacturer reports Safety Issue TO If a Safety Issue is found, a Recall could be issued Recalls Investigations (No investigations available for this search.) Complaints Manufacturer Communications Loading Recalls...

• Your Safety Complaints and Safety Complaints of others TO NHTSA may conduct a Safety Investigation OR Manufacturer reports Safety Issue TO If a Safety Issue is found, a Recall could be issued Recalls Investigations Complaints Manufacturer Communications Loading Recalls...

• SAP EHS Management, environment, health, and safety does not include rights to SAP EHS Management, Product Safety and SAP EHS Management, Product REACH and Compliance.The SAP Enterprise Integration EHS Safety Issue Mobile App Software is Runtime Software that may require an additional component downloaded from a third party mobile application store.

• The licensed SAP Enterprise Integration EHS Safety Issue Mobile Apps includes SAP Mobile Platform (“Mobile Platform”) and/or SAP Sybase 365 Mobiliser Platform (“Mobiliser Platform”) as Runtime Software.

• Glenn County General Plan, Volume II, Issues, Public Safety Issue Paper, Figure 4-2.

More Definitions of Safety Issue

Safety Issue means, with respect to a given Collaboration Product or Other Component used in combination with such Collaboration Product: [***].

Safety Issue means instances, in which either the FDA or the EMA require that the Development, Manufacture, or Commercialization of a CoDev Product be stopped.

Safety Issue means a serious adverse event, toxicology finding or other serious safety issue or tolerability finding or issue with respect to a Licensed Product administered to humans that, as of the Effective Date, was not publicly known to be an adverse event, toxicology finding or other safety or tolerability finding or issue associated with positive allosteric modulators of GABA-A, as a class.

Safety Issue means, with respect to a Product, [**].

Safety Issue means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for the Other Party’s Compound, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.

Safety Issue means any event, report, data or information, which could cause a re-evaluation of the safety of the Shire Product including, but not limited to, Suspected Adverse Drug Reaction and Unexpected Suspected Adverse Drug Reaction.

Safety Issue means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for the Novartis Study Drugs or Olema Study Drug, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.