But the most effective new power has been the risk evaluation and mitigation system (REMS).
"The small company owners assessed and documented inventory, completed risk evaluation, contingency plans, Y2K tests, and remediation plans, " Maramdo said.
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.
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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The fund's stock-picking process includes a scan of companies growing faster than their peers, a risk evaluation of balance sheets and the stability of cash flows, and a hard look at valuation, to see if a stock is worth the price.
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.
But now there is the option of something stronger, known as a risk mitigation and evaluation strategy (REMS).
Increasingly, however, major institutional investors are integrating sustainability considerations into their investment decisions, especially evaluation of risk and long-term value creation of stronger sustainability performance.
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This may finally bring proper evaluation of credit risk and the consolidation of crowded industries.
The aim was to break out of collateral-based lending, making no-collateral loans based on evaluation of various risk factors.
The Obama administration has required stricter evaluation systems as a condition for certain grants, and the city is at risk of losing hundreds of millions of dollars in federal funding if an evaluation system isn't put in place.
Physicians could then better decide whether to refer women at higher risk for ovarian cancer to gynecologic oncologists for evaluation and surgery.
Beyond their basic evaluation of soldiers and veterans considered at-risk of suicide, the researchers are also interested in determining whether all soldiers (and, perhaps, some civilians) would benefit from some level of omega-3 supplementation to ward off mental health problems.
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The BP executive, who headed the company's safety and operational risk department, said that he and then-chief executive Tony Hayward decided to exclude a broader "systematic evaluation" from the scope of the investigation.
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The key to daring new things is an evaluation process that lets you learn quickly and either fail fast or keep improving, minimizing the resources at risk and maximizing opportunities for learning.
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State Commissioner of Education John King had asked for the information in a letter to the city last month, saying the city was at risk for losing more aid if it couldn't show that it was taking steps to prepare for a new evaluation system.
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