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Medical Devices

Electrostimulation Device a 'Breakthrough': FDA

FDA grants Checkpoint Surgical a breakthrough device designation for the companys brief electrostimulation therapy system for nerve regeneration.

Human Drugs

Hangzhou Badi CGMP Violations

FDA warns Chinas Hangzhou Badi Daily Use Chemical Company about CGMP and other violations in its manufacturing of finished drugs.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Enprani Co., and Hangzhou Badi Daily Use Chemical.

Human Drugs

Public Citizen Sues FDA Seeking Cesium Chloride Ban

Public Citizen 9/10 sues FDA in Washington, DC federal court over the agencys inaction to respond to the groups 7/2018 citizen petition urging a ban o...

Biologics

FDA Develops Hepatitis A Immune Response Biomarker

FDA says its scientists have developed a way to determine whether dendritic cells are primed to trigger production of antibodies against Factor VIII p...

Human Drugs

Ipca Laboratories FDA-483

FDA releases an FDA-483 issued to Indias Ipca Laboratories with three inspection observations.

FTC Warns Makers of CBD-Infused Products

The Federal Trade Commission warns three companies that they need credible and reliable scientific evidence to make health claims for CBD-infused prod...

Medical Devices

Metrix Recalls IV Flexible Bags

The Metrix Co. (Dubuque, IA) recalls several lots of its empty IV flexible containers due to the potential for leakages from the IV bag at the chamber...

Federal Register

Info Collection for Symbols in Device Labeling

Federal Register notice: FDA submits to OMB an information collection extension for Medical Devices; Use of Symbols in Labeling Glossary To Support t...

Human Drugs

CGMP Issues in Enprani Inspection

FDA warns South Koreas Enprani Co. about CGMP and other violations in its manufacturing of finished pharmaceuticals.