FDA Related News

Appeals Court Sends Lantus Case Back to District Court

An appeals court has sent back to a federal district court an antitrust case involving the Sanofi Lantus SoloStar insulin device in which purchasers s...

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes one medical product company R-Garden.

Human Drugs

FDA OTC Switch for Voltaren and Pataday Drugs

FDA approves the switch of three prescription drugs to over-the-counter status for GlaxoSmithKlines Voltaren, Alcons Pataday twice daily and Pataday o...

Medical Devices

FDA Clears SureMAX-X Cervical Spacer

FDA clears an Additive Implants 510(k) for the SureMAX-X Cervical Spacer, a 3D-printed titanium spinal surgery device.

Biologics

CBER Plans 21 Guidances This Year

CBER releases a list of 21 guidances it may develop and issue in 2020.

Human Drugs

Former Generic Drug Exec Pleads Guilty

The Justice Department says a former senior generic drug company executive is the third person to plead guilty to participating in a conspiracy to fix...

Federal Register

Docket Opened for Vaping Injury Reports

Federal Register notice: FDA opens a docket to obtain information about vaping products and associated lung injuries.

Federal Register

Reg Review Period for Endorecherches Intrarosa

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Endorecherches Intrarosa (prasterone).

Federal Register

Stimulant Use Disorder Drug Development Meeting

Federal Register notice: FDA announces a 3/10 public meeting entitled Patient-Focused Drug Development for Stimulant Use Disorder.

Medical Devices

Phillips Respironics Recalls Triology EVO Ventilators

Philips Respironics recalls its Trilogy EVO Ventilator and Trilogy EVO Universal Ventilator due to a software defect.