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FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs. The Office of Global Regulatory Operations and Policy (GO), [1] also known as the Office of Regulatory Affairs (ORA), [2] is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation ...
The National Center for Toxicological Research (NCTR) is a branch of the U.S. Food & Drug Administration (FDA) located in Jefferson, Arkansas.Established in 1971, the Center conducts scientific research to provide reliable data for Food & Drug Administration decision-making and develops innovative tools and approaches that support its public health mission.
(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a new rule that gives it more oversight of diagnostic tests developed by them.
The 2002 Medical Device User Fee and Modernization Act (MDUFA) first granted FDA the authority to collect user fees from industry to help the FDA improve efficiency, quality, and predictability of medical device submission reviews; the medical device user fee program has been reauthorized several times with the most recent in 2022.
Trinity delivered one lab building totaling 155,000 square feet and two GMP buildings totaling 372,000 square feet at Phase 1 of the Spark development in late 2023. No tenants have signed to date ...
The new 34,500-square-foot building will feature laboratory fit-ups along with office amenities, including conference rooms with audio-visual equipment, a lounge, break rooms, shared printers ...
Preliminary clearing and grading of the proposed site began in 2010, construction on the site's power plant began in 2013, and construction of the lab began in 2015. On January 2, 2013, the Department of Homeland Security accepted a transfer of land from the State of Kansas for the site of the facility.