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Medical Devices

Regulating Mobile Medical Apps

CDRH director Jeffrey Shuren says FDA is leading a group of international medical device regulators who are developing policies to regulate software a...

Human Drugs

6th Circuit Finds Medication Guide Suit Preempted

The 6th Circuit Court of Appeals says a suit alleging failure to provide a medication guide is preempted by federal law.

FDA General

Warning Letters Released 7/3/2018

FDA releases its latest batch of Warning Letters that include Foshan Jinxiong Technology and Sichuan Friendly Pharmaceutical Co.

Human Drugs

Fagron Recalls 2 Lots of Neostigmine Methylsulfate

Fagron Sterile Services recalls two lots of neostigmine methylsulfate 5ml syringes after a confirmed customer complaint that some syringe units are in...

Human Drugs

Potential Advisors Conflicts of Interest Aired

The BMJ reports on a Science investigation into potential conflicts of interest with some FDA advisory committee members.

Human Drugs

Sichuan Friendly Pharmaceutical CGMP Deviations

FDA warns Chinas Sichuan Friendly Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceutical ingredients.

DoJ Policy Wants Coordination of Penalties Against Companies

Two attorneys say the Justice Department is quietly implementing a new policy encouraging coordination among regulators in imposing punishment on comp...

Medical Devices

FDA Clears IsoRays GammaTile Brachytherapy

FDA clears an IsoRay 510(k) for its GammaTile brachytherapy technology that uses proprietary Cesium-131 seeds within customizable collagen-based carri...

Human Drugs

Pallone Wants REMS Abuse Hearing

New Jersey Democrat Frank Pallone says the House Energy and Commerce Committee should hold a hearing on drug company efforts to use the FDA REMS proce...

Human Drugs

Oculocare Medical App Cleared for Macular Degeneration

FDA clears an Oculocare Medical 510(k) for Alleye, a mobile medical software application indicated for detecting and monitoring age-related macular de...