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And some cancer specialists say that Dr. Pazdur, after pushing for years to lower approval standards, has toughened them recently after being criticized for approving drugs that were later shown to have few benefits.
A more reasonable approach would be stricter approval standards.
However, many applications have yet to reach the market, because many governments disagree on how to set the approval standards.
If the legislation passes but has weakened approval standards, the agency may not need much of its staff.
The National Association of Small Business Professionals adopts tougher and more stringent approval standards for its accredited business program.
In recent months, the agency has stepped up its oversight of food safety and has promised to tighten approval standards for medical devices.
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5 Though an orphan drug designation does not formally change the statutory approval standard, studies show that orphan drugs are often approved on the basis of clinical trials that would be insufficient for traditional non-orphan products, such as small, non-randomized, unblinded, single arm trials.
Site parameters are specified in a standard design approval, standard design certification, or manufacturing license.
Yet at the advisory committee meeting in December, agency officials said that they had not used delayed disease progression as an approval standard for drugs meant as an initial treatment for breast cancer that has metastasized.
In 1999, in response to government pressure to expand low-to-moderate-income homeownership, Fannie Mae began to lower its credit-approval standards.
Zheng Xiaoyu, the former head of China's State Food & Drug Administration, was removed from office in 2005 and expelled from the Communist Party in March for taking bribes that allowed companies to get around drug-approval standards, the Chinese media reported.
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