Safety Issue definition

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.

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.

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 Complaints Manufacturer Communications Loading Recalls...

• All conditions within an original permit may be appealed, subject to the appeal rights set forth in 561 IAC Chapter7.

• If the Executive Officers approve a course of action to address such Material Safety Issue, then the Parties shall thereafter take all actions necessary to implement such course of action.

• A surface extending outward and upward from the periphery of the horizontal surface at a slope of 20 to 1 for a horizontal distance of 4,000 feet is known as a “conical surface.” 6 San Bernardino County General Plan Update, Background Report, Man-made Hazards, Airport Safety Issue.

• Regulatory Analysis for Resolution of Unresolved Safety Issue A-46, `Seismic Qualification of Equipment in Operating Plants,'" U.S. Nuclear Regulatory Commission, February 1987.

More Definitions of Safety Issue

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

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.

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 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, with respect to a Product, [**].