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Human Drugs

Lipitor Decision Threatens Patent Settlements: WLF

Washington Legal Foundation chief counsel Richard Samp criticizes a Third Circuit Court of Appeals decision in a Lipitor patent settlement case.

Marketing

Lawsuit Ads Can Hurt Public Health: Report

A U.S. Chamber report outlines steps, including by FDA, that can be taken to restrict lawsuit advertising that it says can harm public health.

Medical Devices

FDA Clears RadiaDyne 510(k) for Radiation Dose Monitor

FDA clears a RadiaDyne 510(k) for two new indications for its OARtrac radiation dose monitoring platform.

Human Drugs

FDA Outlines Opioid Crisis Activities

FDA commissioner Scott Gottlieb outlines the agencys efforts as part of HHS to address the nations opioid crisis.

Human Drugs

FDA Rejects PTC Therapeutics NDA for Ataluren

FDA sends PTC Therapeutics a complete response letter for its NDA for ataluren for treating nonsense mutation dystrophinopathies.

Human Drugs

FDA Complete Response on Antares Testosterone Therapy

FDA issues Antares Pharma a complete response letter on its NDA for Xyosted (testosterone enanthate) injection for testosterone replacement therapy.

Federal Register

Ovrette Not Withdrawn Due to Safety/Effectiveness: FDA

Federal Register notice: FDA determines that HRA Pharmas Ovrette (norgestrel) tablets, 0.075 mg, was not withdrawn from sale for reasons of safety or ...

Medical Devices

OriGen Biomedical Recalls Dual Lumen Catheter

OriGen Biomedical recalls two lots of its Reinforced Dual Lumen catheter due to a separation risk involving the clear extension tube from the hub conn...

Federal Register

Class 2 for Zinc Transporter 8 Autoantibody Immunological Test

Federal Register notice: FDA classifies zinc transporter 8 autoantibody immunological test systems into Class 2 (special controls).

Human Drugs

CGMP Problems Found at Indias Vital Laboratories Private

FDA warns Indias Vital Laboratories Pvt. about CGMP violations at its API facility in Gujarat.