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 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 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

• In the event that a Party determines that (a) a Safety Issue exists or is reasonably imminent, or (b) Emergency Works need to be performed, each Party shall have the right, in its sole discretion, to demand that the Charging Equipment or Charging Stations immediately cease operations for as long as such Party determines is necessary to resolve any existing or imminent Safety Issue or sufficiently perform the requisite Emergency Works.

• Dominion Energy Virginia and its designees shall have the right to review and inspect the Charging Equipment (i) immediately, if a potential Safety Issue exists (as determined by Dominion Energy Virginia in good faith) or (ii) promptly upon notice to the School Board.

• No. 1 Page Procedure Health Safety Issue Date June status Active EARLY SAFE RETURN TO WORK PROGRAM INTRODUCTION Precision Industries the importance of having fair and consistent practices for accommodating employees who have been ill, injured or permanently disabled, to enable their early and safe return to work.

• If a Patient Safety Issue is identified as a result of any disclosure, the Compliance Officer (or designee) shall take immediate steps to mitigate any associated risk while the Patient Safety Issue is being corrected.

• Finally, LWL will make available to all employees a Safety Issue Form.

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 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 instances in which the FDA and the EMA require that the Development, Manufacture or Commercialization be stopped.

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

Safety Issue means any event, report, data or information which could cause a re-evaluation of the safety of the Product including, but not limited to, Adverse Events and Adverse Reactions;