Sentence examples for premarket assessment from inspiring English sources

"We have placed far more resources and requirements upon premarket assessment of drugs than on postmarket".

Using surgical bypass with autogenous vein as the standard for comparison, OPGs were developed for nine safety and efficacy measures that could be utilized in the premarket assessment of new devices in CLI.

Recent initiatives are developing innovative study designs to improve the reliability of premarket assessment on the use of medical devices in "real-world" settings [ 23, 24].

In addition, these patients need to be included to enable premarket assessments of the risks and benefits of medications related to suicidal ideation, suicidal behavior, and suicide in this population [ 29].

While the FDA has issued draft guidance on the types of studies recommended to evaluate MRTPs [ 3], it has acknowledged the difficulties inherent in making premarket assessments of the effect that the introduction of a MRTP would have on the population.

A premarket safety assessment of food microbes is based on four mainstays (establishing identity, body of knowledge, possible pathogenicity, and final use) according to the European Food Safety Authority (EFSA) [ 53].

Hansen calls this support for mandatory premarket safety assessments "huge".

Industry's compliance with GLP has caused many tens of thousands of published independent chronic toxicity studies any of which might have determined the allowable "safe" daily dose of a chemical to be excluded from premarket approval risk assessments and substituted with financially conflicted, yet GLP-compliant, data from the chemical's manufacturer.

In a statement to the Los Angeles Times following the action, AMA Board of Trustees member Patrice Harris said, "Recognizing the public's interest in the safety of bioengineered foods, the new policy also supports mandatory FDA [Food and Drug Administration] premarket systemic safety assessments of these foods as a preventive measure to ensure the health of the public.

In July 2008, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee met to discuss the role of CV assessment in the premarketing and postmarketing settings.

In July 2008, the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA met to discuss CV risk with oral antidiabetes agents and the role of risk assessment in the premarketing and postmarketing setting.