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NJ Proposes Limits on Payments, Gifts to Prescribers

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Attorney Serra Schlanger says New Jersey is considering a proposal to restrict drug company payments and gifts to healthcare profe...

Abbott Alinity ci-Series Instruments Cleared

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FDA clears an Abbott 510(k) for its Alinity ci-series instruments for clinical chemistry and immunoassay diagnostics.

HHS Needs Better Opioid Treatment Evaluation: GAO

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The Government Accountability Office says HHS needs a better way of assessing the effectiveness of its efforts to combat the opioi...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Accelerated Analytical Laboratories, Aztex Enterprises and Kim Chem...

3 Reps Want to Meet with Gottlieb on Essure Study

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Three House members raise concerns about FDA oversight of a Bayer post-marketing study of its Essure birth control device that app...

ICH Guidance Addendum on Trial Statistical Principles

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FDA publishes an International Council For Harmonization guidance entitled E9 (R1) Statistical Principles for Clinical Trials: Add...

6 Medical Device Classification Notices

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Federal Register notice: FDA publishes six medical device classification notices.

FDA Reopens Comments on Device Quality Program

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Federal Register notice: FDA reopens the comment period to allow additional time for comments related to a workshop on Voluntary M...

FDA Lab Findings Confirm Contaminated Docusate Sodium

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FDA says its lab findings again link Rugby Dioctos oral liquid docusate sodium to Burkholderia cepacia.

Cardene SR Not Withdrawn Over Safety/Effectiveness: FDA

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Federal Register notice: FDA determines that EKR Therapeutics hypertension drug Cardene SR (nicardipine HCl) extended-release caps...