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Human Drugs

Feds Looking Into Janssen False Claims Act Allegations

Reuters says the Justice Department is looking into allegations involving several Johnson & Johnson drugs.

FDA General

FDA Implementing Cloud-based Data Management: Simpson

FDA chief information officer Todd Simpson describes the agencys move to a data management platform that can incorporate cloud storage,

Human Drugs

A Third of Drug Approvals have Post-market Safety Issues: JAMA

A new study published in JAMA finds that nearly a third of recently approved drugs resulted in adverse events that led to new boxed warnings or safety...

Human Drugs

C.O. Truxton Recalls Phenobarbital and Amitriptyline

C.O. Truxton expands an ongoing recall to now include all phenobarbital and amitriptyline tablets that were repackaged into a Truxton label due to the...

FDA General

POGO Says HHS Gags Employees

The Project on Government Oversight says HHS is attempting to restrict its employees from communicating to Congress as whistleblowers reporting wrongd...

Human Drugs

Gottlieb Approved by Senate as Next FDA Commissioner

The Senate votes to approve the nomination of Scott Gottlieb as the next FDA commissioner.

Medical Devices

Industry Task Force Wants FDA Action on Secure Lifecycle

An industry cybersecurity task force recommends FDA action to increase adoption of a medical device secure development lifecycle.

Medical Devices

QS Violations Found at Switzerlands Lonza Group

FDA warns Switzerlands Lonza Group about Quality System violations in its contract manufacturing of Class 2 medical devices.

Human Drugs

High Pace of Biotech Approvals Seen to Continue

The Tufts Center for the Study of Drug Development says it expects the approval rate of biotech products over the 2000-16 period of 10 to 20 approvals...

Medical Devices

CDRH to Roll Out Digital Health Unit

CDRH says it is establishing a centralized digital health unit within the Office of the Center Director to ensure proper coordination and consistency ...