Tag Archive for: FDA

NCCS comments on FDA’s draft guidance for in vitro companion diagnostic devices

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NCCS filed comments on the Food and Drug Administration’s Draft Guidance for Industry and Food and Drug Administration Staff: In Vitro Companion Diagnostic Devices on October 12, 2011. The Draft sets out a proposed framework for drug and test makers to use in developing targeted treatments and new tests to help identify patients most likely to benefit […]

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House passes FDA’s $6.4 billion fee plan for drug reviews

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The $6.4 billion accord that Teva Pharmaceutical Industries Inc. (TEVA), Johnson & Johnson (JNJ) (JNJ) and other companies reached with U.S. regulators to fund new medicine and device reviews through 2017 passed the House of Representatives. The House voted late yesterday 387-5 in favor of the legislation, which is similar to a measure approved by […]

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