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NJ Proposes Limits on Payments, Gifts to Prescribers

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

Medical Devices

Abbott Alinity ci-Series Instruments Cleared

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

Human Drugs

HHS Needs Better Opioid Treatment Evaluation: GAO

The Government Accountability Office says HHS needs a better way of assessing the effectiveness of its efforts to combat the opioid addiction crisis b...

Human Drugs

Latest FDA Warning Letters

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

Medical Devices

3 Reps Want to Meet with Gottlieb on Essure Study

Three House members raise concerns about FDA oversight of a Bayer post-marketing study of its Essure birth control device that appears to be behind sc...

Federal Register

Workshop on Collecting Patient Experience Data

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

Human Drugs

FDA Will Explore New Opioid Packaging: Gottlieb

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

Federal Register

Cardene SR Not Withdrawn Over Safety/Effectiveness: FDA

Federal Register notice: FDA determines that EKR Therapeutics hypertension drug Cardene SR (nicardipine HCl) extended-release capsule (30 mg, 45 mg, a...

Human Drugs

FDA Clears 3 Diagnostic Tests for Melinta Therapeutics Baxdela

FDA clears three antimicrobial susceptibility tests for determining the appropriate usage of Melinta Therapeutics Baxdela (delafloxacin), a fluoroquin...

Human Drugs

FDA Approves a Jannsen sNDA for Xarelto

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