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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Cardene SR Not Withdrawn Over Safety/Effectiveness: FDA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...

FDA Clears 3 Diagnostic Tests for Melinta Therapeutics Baxdela

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FDA clears three antimicrobial susceptibility tests for determining the appropriate usage of Melinta Therapeutics Baxdela (delaflo...

FDA Approves a Jannsen sNDA for Xarelto

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FDA approves a Janssen Pharmaceuticals supplemental NDA for a 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the cont...

FDA Will Explore New Opioid Packaging: Gottlieb

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As part of the Trump Administrations national public health emergency declaration against opioid abuse, FDA commissioner Scott Got...

Workshop on Collecting Patient Experience Data

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Federal Register notice: FDA announces a 12/18 public workshop to discuss methodological approaches for those intending to collect...