FDA Related News

Human Drugs

FDA Warns of Medication-Assisted Treatment Drug Risks

FDA cautions healthcare providers not to withhold two opioid addiction drugs from patients also taking central nervous system depressants.

FDA Warns 13 Web Firms re Unlawful Drug Sales

FDA tells 13 Internet companies to stop selling unapproved new drugs and misbranded drugs in the U.S.

Medical Devices

FDA Clears Revamped Pentax Duodenoscope

FDA clears a Pentax of America 510(k) for the first duodenoscope with a disposable distal cap, a new feature that is intended to improve access for cl...

Medical Devices

Medical Device Inspection Changes in Reauthorization

Attorneys review medical device inspection changes included in the FDA Reauthorization Act of 2017.

Human Drugs

CGMP Violations at Koreas Firson Company

FDA warns Koreas Firson Company about CGMP violations in the production of finished pharmaceuticals.

Human Drugs

FDA OKs Glaxo/Innoviva Triple Therapy for COPD

FDA approves a GlaxoSmithKline and Innoviva NDA for a once-daily, single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vila...

Medical Devices

FDA Clears Arkis Bio Ventricular Drainage Catheter

FDA clears an Arkis BioSciences 510(k) for its new CerebroFlo external ventricular drainage catheter.

Human Drugs

Wuxi Medical CGMP Violations Found

FDA warns Chinas Wuxi Medical Instrument Factory about CGMP violations in its manufacturing of finished pharmaceuticals.

Medical Devices

Quality System Issues at Preservation Solutions

FDA warns Preservation Solutions about Quality System violations in its manufacturing of organ transplant preservation solution.

FDA General

Real World Evidence on Definitions Under Development: Gottlieb

FDA commissioner Scott Gottlieb says the agency is developing a guidance document on real world evidence (RWE) consensus definitions that is intended ...