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  2. FDA wants to regulate thousands of lab tests that have long ...

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    In the 1970s and '80s, most lab-based tests were “lower risk, small volume” products used mostly for local patients, the FDA noted Friday. Over time, laboratory-developed tests have grown into ...

  3. Office of Global Regulatory Operations and Policy - Wikipedia

    en.wikipedia.org/wiki/Office_of_Global...

    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 ...

  4. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    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 ...

  5. File:FDA Bldg 62 - Exterior (5161375340).jpg - Wikipedia

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    Main page; Contents; Current events; Random article; About Wikipedia; Contact us; Donate

  6. FDA brings lab tests under federal oversight in bid to ...

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    The FDA already reviews tests and kits made by medical device manufacturers. But labs, large hospitals and universities that develop their own in-house tests have been able to market them without ...

  7. US FDA tightens scrutiny of lab-developed tests with new rule

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    (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.

  8. Center for Drug Evaluation and Research - Wikipedia

    en.wikipedia.org/wiki/Center_for_Drug_Evaluation...

    FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.

  9. FDA gives first safety sign-off for company selling lab-grown ...

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