Sometimes, there are going to be risks and unintended consequences associated with a particular mitigation strategy that we consider.
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.
FORBES: Merck Wins Victory Over Skeptics With Hepatitis C Approval
Because vandetanib affects the electrical activity of the heart, potentially lethally, it is being sold under a Risk Evaluation and Mitigation Strategy (REMS).
FORBES: AstraZeneca's Victory Highlights Difficulty Of Cancer Drug Development
Our plan to distribute technical resources has proven to be a good mitigation strategy to enable ongoing operations throughout a localized extreme event.
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.
FORBES: FDA Approves Lomitapide For Homozygous Familial Hypercholesterolemia
In the report, Facebook earned poor marks for coal intensity (53.2 percent, the second highest of the 10 companies rated), a D for transparency, an F for infrastructure siting, and a D for mitigation strategy.
FORBES: Facebook Commits to Green Energy -- But Can It Deliver?
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.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
The working group will gather scientific evidence to determine the role of coastal vegetated ecosystems in carbon storage and sequestration, encourage the inclusion of these systems in national carbon accounting, and consider their conservation and restoration as a viable mitigation strategy under existing climate regulation policies.
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).
In September 2011, MOET adopted its Action Plan to implement the National Strategy for Natural Disaster Prevention, Response and Mitigation 2011-2020, acknowledging and aiming to tackle both the impacts of climate change and disasters on the education sector and the important role education can play in mitigating these risks.
The DOD cyberspace strategy is too narrowly focused on cyberspace as technology, information as data, and the mitigation of risks to technological infrastructure as a way of achieving information assurance.
应用推荐