Sentence examples for approval standard from inspiring English sources

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.

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.

The National Association of Small Business Professionals adopts tougher and more stringent approval standards for its accredited business program.

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 agency declared THG an unapproved new drug that "cannot be legally marketed without F.D.A. approval under the agency's rigorous approval standards".

Mr. Levinson's report said the F.D.A. rejected 96percentt of generic drug applications, and he suggested that the agency should give applicants better guidance about approval standards.

In recent months, the agency has stepped up its oversight of food safety and has promised to tighten approval standards for medical devices.