FDA Related News

Federal Register

Class 2 for Upper Limb Tremor Stimulator

Federal Register notice: FDA classifies the external upper limb tremor stimulator into Class 2 (special controls).

Human Drugs

Teva Sues FDA Over Generic Restasis Exclusivity

Teva asks a federal court to order 180-day exclusivity for its Restasis ANDA.

FDA General

Walmarts Yiannis Named FDA Deputy Commissioner

FDA commissioner Scott Gottlieb announces the appointment of Walmart executive Frank Yiannis as deputy commissioner for food policy and response.

Medical Devices

Stakeholders Want More Device Accessories Reclassified

Stakeholders ask for changes to an FDA list of medical device accessories proposed for down-classification to Class 1.

CDRH Surveillance/Enforcement on Promo Efforts

A CDRH official says surveillance and enforcement concerns involving promotional or adverting efforts include unapproved devices, modified devices, an...

Human Drugs

Teva Sues FDA Over Generic Restasis Exclusivity

Teva asks a federal court to order 180-day exclusivity for its Restasis ANDA.

Medical Devices

FDA Clears MC3 Crescent Jugular Catheter

FDA clears an MC3 510(k) for the Crescent Jugular Dual Lumen Catheter for use in extracorporeal membrane oxygenation.

Human Drugs

FDA Wants Generic Drugs Harmonized Globally

FDA commissioner Scott Gottlieb says the agency is seeking international harmonization of generic drug scientific and technical requirements as a way ...

Human Drugs

Groups Praise FDA Expansion Cohorts Guidance

Five stakeholders respond to an FDA draft guidance on use of expansion cohorts in some oncology trials.

Medical Devices

FDA Cybersecurity MOU with Homeland Security Department

FDA and the Department of Homeland Security sign a Memorandum of Understanding on medical device cybersecurity coordination.