They are much more wary and more open to risk mitigation than in the past.
Then, each critical-infrastructure operator would have a third-party, commercial auditor assess its cybersecurity risk mitigation plans.
But now there is the option of something stronger, known as a risk mitigation and evaluation strategy (REMS).
Another situation where these risk mitigation plans were used involved scheduled narcotics that could be accidentally ingested by children.
The Centre, run by NIEM, aims to improve educational management capacities for climate change response and disaster risk mitigation.
The difference between normal resource discussions and this one is your newfound ability to specify what new risk mitigation the new resources will enable.
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In fact, nobody has done rigorous work to evaluate which risk mitigation strategies are best suited for dealing with certain kinds of side effects.
The risk mitigation plans presupposed that FDA and the drug makers had legal, if actual control over what doctors did and how they prescribed medicines.
This could be accelerated by mandating that federal contractors report on risk mitigation steps taken with regard to any ties to U.S.-sanctioned states in the course of their application process.
The WEF this year is setting out to create a stronger risk mitigation framework and early warning mechanism for the globe, specifically designed to deal with the tensions and dilemmas that abound.
Firms that are successful in building these capabilities have enormous opportunities, not just for risk mitigation, but for the creation of business value through proactive management of supply chains and identification of new areas for growth.
It found no evidence that Krung Thai required risk-mitigation measures such as identification of anchor tenants.
Because career success depends so heavily on happiness and attitude, you need to treat these factors differently, and not just as two more parts of an overall risk-mitigation model.
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But the most effective new power has been the risk evaluation and mitigation system (REMS).
The business is fully behind this effort, and is integral to our continued risk identification and mitigation efforts.
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The Risk Evaluation and Mitigation Strategy (REMS) targets extended-release (ER) and long-acting (LA) opioid drugs, including prescription medications containing oxycodone hydrochloride.
There were fears that FDA would saddle Merck with an onerous Risk Evaluation and Mitigation Strategy (REMS) program, which could reduce sales.
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The FDA has just released the actual Risk Evaluation and Mitigation System (REMS) for Avandia and companion drugs Avandaryl and Avandamet.
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Because vandetanib affects the electrical activity of the heart, potentially lethally, it is being sold under a Risk Evaluation and Mitigation Strategy (REMS).
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The FDA will also ask the panel to evaluate a proposed Risk Evaluation and Mitigation Strategies (REMS) if the drug gains approval.
But Sabril needed a Risk Evaluation and Mitigation System (REMS), FDA jargon for a plan that ensures drugs are only used when benefits outweigh risks.
In order to get approved, Qnexa will probably need a risk evaluation and mitigation strategy (REMS), post-market studies, and warnings in its label, Carr says.
Because of the risk of liver toxicity, JUXTAPID is available only through a restricted program called the JUXTAPID Risk Evaluation and Mitigation Strategy (REMS) Program.
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At first glance, it seems that this risk evaluation and mitigation system (REMS) is not as onerous as it might have been, and that may leave the FDA open to further criticism.
In addition to risk and burden mitigation for IPO issuers, the JOBS Act substantially reduced limitations on publication of reports and recommendations by research analysts at investment banks participating in the public offerings.
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The two companies filed a New Drug Application on Jan. 9, 2009 and learned in November that the agency extended the review date of Horizant to Feb. 9 to perform a risk evaluation and mitigation plan for the drug.
The FDA approved Kynamro with a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use, including prescriber and pharmacy certification, and documentation of safe-use conditions, which requires a prescription authorization form for each new prescription.
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Investors are expecting that there will not be a black box warning on the drug, and that any Risk Evaluation and Mitigation Strategy (REMS) plan these are special plans designed to limit who gets a medicine will be relatively lights.
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The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class.
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