FDA Related News

Human Drugs

Gilead Asks 9th Circuit to Rehear HIV Drug Case

Gilead, supported by the Washington Legal Foundation, asks the 9th Circuit Court of Appeals to rehear a False Claims Act case involving three HIV drug...

Federal Register

PMA Critical to Quality Pilot Program

Federal Register notice: FDA announces a Premarket Approval Application Critical to Quality pilot program.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Dynavision International and HomeoCare Laboratories.

Many Doctors Have Twitter Conflicts of Interest

Oregon Health & Sciences University researchers say many hematologists and oncologists who frequently tweet cite drugs positively from companies with ...

Human Drugs

FDA Urges Industry Comments on Continuous Manufacturing

FDA continues to urge the adoption of continuous manufacturing by drug manufacturers and seeks comments on the emerging field by 9/21.

Biologics

FDA Accepts Adello BLA for Neupogen Biosimilar

FDA accepts for review an Adello Biologics BLA for a biosimilar candidate referencing Amgens Neupogen (filgrastim), indicated for treating neutropenia...

Medical Devices

Guidance on Age, Race Data in Device Clinical Studies

FDA issues a final guidance on Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.

Medical Devices

Pilot Program on Early PMA Critical-to-Quality Controls

FDA announces a pilot program on Approval Application Critical to Quality which aims to evaluate device design and manufacturing process quality infor...

Human Drugs

Galena Bio Pays Fine in Kickback Case

Galena Biopharma agrees to pay the federal government more than $7.55 million to resolve allegations under the civil False Claims Act that it paid kic...

Human Drugs

Janssen Scraps Hep C Therapy Due to Saturated Market

Janssen Sciences discontinues development of its investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct acting antivira...