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Higher productivity and a better place to work: practical ideas for owners and managers of small and medium-sized industrial enterprises. International Labour Organization. ISBN 978-92-2-106409-1. (Action manual) Thurman, Joseph E.; A. E. Louzine; Kazutaka Kogi (1988).
The Clinical Laboratory Improvement Act of 1988 (CLIA 88) was passed in the USA subsequent to the publication of an article in November 1987 in The Wall Street Journal entitled "Lax Laboratories: The Pap Test Misses Much Cervical Cancer Through Labs Errors", which alerted the public to the fact that a pap smear may be falsely negative.
CSTDs generally follow one of two design concepts, using either a physical barrier or an air-cleaning technology to prevent the escape of hazardous drugs into the work environment. Physical barrier - Blocking the unintended release of drug into the surrounding environment or the intake of environment contaminates into a sterile drug pathway. [8]
Under the government's plan, most newly developed tests that pose a high risk — such as those for life-threatening diseases — will need to be FDA approved within 3 1/2 years. Lower risks tests ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Unlike its previously approved product for small nicks and cuts, the new gel, Traumagel, can be used for life-threatening injuries, CEO and co-founder Joe Landolina told Reuters.
Mark Cuban, CEO of Cost Plus Drugs, told BI that AI's impact on a company's workforce will be determined by how well the technology is implemented.
Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, hearing aids, and dental amalgams are examples of class II devices. Class III: Devices that are approved by the premarket approval (PMA) process, analogous to a New Drug Application. These tend to be devices that are permanently implanted into a ...