Mitigation Strategy definition
Examples of Mitigation Strategy in a sentence
For the purposes of this Amendment No. 5, the “E.A.S.E.™ Program” means the then-current ENTEREG Access Support and Education (E.A.S.E.™) Program implemented by the Parties as part of the Risk Evaluation and Mitigation Strategy approved by the FDA for the POI Product.
If a youth is taking clozapine and the pharmacy will not dispense a 30-day supply, the prescription should include refills sufficient to provide a 30-day supply once Clozapine Risk Evaluation and Mitigation Strategy- required lab work is obtained/documented.
Because the land plan for the PVSP was finalized while the Plan was still in development, some of the avoidance and minimization measures and conservation requirements in the PVSP Mitigation Strategy differ slightly from the Conditions on Covered Activities in Chapter 6, as described in Appendix N of the Plan.
The Trust would expect Shepway District Council to make well-evidenced policy provision for this increased recreational pressure in its Draft Local Plan, or in the form of an SPA/SAC Access Management and Mitigation Strategy.
On July 9, 2012, the Food and Drug Administration (FDA) approved a Risk Evaluation and Mitigation Strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications.
Mitigation Strategy Presentation in the RAMP and GRC The utility’s RAMP filing will provide a ranking of all RAMP Mitigations by Cost-Benefit ratios.
Emerging Threat Reports may contain the following: (i) Executive Summary; (ii) Technical Threat Details; (iii) Attack Vector; (iv) Detection Capabilities and Indicators; (v) Mitigation Strategy and Recommendations; and/or (vi) References to additional resources.
Auxilium shall be responsible for complying with the requirements of the Risk Evaluation and Mitigation Strategy (the “REMS”) for the Product as updated from time to time and shall, through the Compliance Committee, discuss the REMS, and any changes thereto, with GSK.
Immediately upon receipt of NDA approval by the FDA for the Product, Transcept shall provide Purdue with a copy of all Regulatory Materials received as part of the approval from the FDA, including a copy of the full prescribing information for the Product (including any patient information, medication guide and/or Risk Evaluation and Mitigation Strategy (“REMS”), if any) for review by Purdue in order for Purdue to determine whether to proceed with the Commercialization of the Product under this Agreement.
Contractor shall ensure prescribers are certified in the Clozapine Risk Evaluation and Mitigation Strategy (REMS) system.