The agreement also bars Australia's patent agency from approving generic versions of a drug while a patent application is pending.
It also represents the general sense of caution on the part of the agency when approving new drugs, and therefore is bad news for companies like Arena Pharmaceuticals, which is expecting an FDA decision on its weight-loss drug at the end of the week.
The charges stunned the FDA. Mr. Liang works in the division in charge of approving new drugs, the agency's most visible and sensitive role.
The FDA s letter informed XenoPort and GlaxoSmithkline that a preclinical finding of pancreatic cancer cells in rats caused the agency to hold off on approving Horizant at this time.
In a note to investors released today, Prudential Equity Group's Timothy Anderson says that the FDA is likely to want even more information about this skin reaction, and that the agency might hold off on approving Galvus for as much as several more months.
The dispute began less publicly in 2006, when a consultant reviewer, Robert Smith, a controversial radiologist formerly at hospitals operated by Yale and Cornell, and several center employees raised concerns that the agency was overlooking safety concerns in approving substandard medical imaging devices for mammograms and colonoscopies.
The Environment Agency could face a legal challenge after approving a new waste and recycling plant in Surrey.
But in a petition filed last month, Genentech (nyse: DNA - news - people ) asks the agency to refrain from publishing the guidance, or approving generics of any Genentech drugs, because the company claims it would be impossible for the FDA to do so without infringing on Genentech's trade secrets.
Richard Pazdur , who heads the FDA's cancer-drug division, told the crowd at the hearing in late September that the agency was rolling on its "merry way" toward approving Iressa until it was "floored" to hear of the drug's failure in the two large trials.
This week, an independent federal agency urged Bruce Babbitt, the secretary of the interior, to reconsider the plans before approving them.
It seems like the agency is just tone deaf to the concerns raised by many members of the community about approving drugs with surrogate endpoints like cholesterol without evidence of a benefit for the disease we are truly trying to treat cardiovascular disease.
FORBES: Merck's Cholesterol Pill Win Is Already Drawing Fire
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