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FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Huron Pharmaceuticals, Lonza Group, Rainbow Gold Products, and Vikshara Trading & Inves...

Human Drugs

FDA Helping Drug Makers on Continuous Manufacturing

CDERs Sau Lee says FDA is taking steps to facility drug manufacturer use of emerging technologies such as continuous manufacturing.

FDA General

HELP Committee Releases Update User Fee Draft for Mark-up

The Senate Health, Education, Labor, and Pensions Committee releases a Managers Amendment to S. 934 FDA Reauthorization Act of 2017 that would reautho...

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.