But in this case a pretty restrictive REMS was still not as bad as expected.
But the most effective new power has been the risk evaluation and mitigation system (REMS).
One hundred rems can cause radiation sickness and 500 rems likely will cause death.
Hammering out a REMS tends to delay FDA approval, and having a REMS can hurt sales.
This is why REMS like this have teeth: they restrict who can prescribe the drugs and how.
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Nonetheless, Rems is returning very useful meteorological data, and scientists are learning to work around its deficiencies.
But now there is the option of something stronger, known as a risk mitigation and evaluation strategy (REMS).
Dominant wind direction identified by REMS has surprised some researchers who expected slope effects to produce north-south winds.
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Right now, FDA foists on drug makers the responsibility to make sure doctors comply with the REMS restrictions.
He is the investigation scientist for REMS, which Spain provided for the mission.
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The FDA continues to support this approach by including company and prescriber compliance as part of its REMS plan.
Rems has also been tracking the hourly and daily changes in air pressure.
For many new drugs, the REMS, not the traditional review of safety and efficacy, may be the most important hurdle.
Analysts at Concept Capital expect this to result in a rejection now, and approval once the REMS is worked out.
If the REMS system had existed then, it might have been possible to keep it around for just those people.
Reason: A REMS program was submitted and led to a three month extension (although not explicitly stated as the reason).
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The need to fine-tune a REMS has become one of the most common reasons for a new drug to be delayed.
The Risk Evaluation and Mitigation Strategy (REMS) targets extended-release (ER) and long-acting (LA) opioid drugs, including prescription medications containing oxycodone hydrochloride.
Obesity drug maker Arena Pharmaceuticals might also face a REMS problem when its lorcaserin goes before an FDA panel on Sept. 16.
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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The rule of thumb is that 100 rems of exposure increases the chance you will die of cancer by 5% or so.
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The agency anticipates that the REMS will limit use of Avandia significantly.
They became dubbed REMS in 2007 when FDA received explicit authority from Congress to demand these arrangements are part of drug approvals.
As with Victoza, there is also a REMS ( read the label).
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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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Between the lack of a unified REMS and the agency obligation to review the citizen petition, generic rivals will likely remain on the sidelines.
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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.
How likely is it in this current situation that those doses would exceed one rem to the body and five rems to the thyroid?
Another obesity drug, Qnexa from Vivus Pharmaceuticals, ran into trouble because an FDA panel wanted its REMS to be even more restrictive than it was.
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