FDA Related News

Medical Devices

AdvaMed Device Sterilization Reg Proposals for EPA

AdvaMed gives the Biden Administration three points to consider as it works with EPA to finalize an updated standard for ethylene oxide emissions from...

Medical Devices

Lobbying Killed VALID Act: ProPublica

A detailed ProPublica analysis says lobbying by several interests killed the inclusion of the VALID act to regulate laboratory-developed tests in the ...

Many Advertised Drugs Have Low Therapeutic Value: Study

Medical school researchers say most DTC ads are for drugs that do not represent an advance over existing treatments.

Human Drugs

Objectionable Conditions in Larkin Hospital IRB

FDA warns the South Miami, FL-based Larkin Community Hospital institutional review board about failing to adhere to statutory and regulatory requireme...

Human Drugs

Fabre-Kramer Resubmits Depression Drug NDA

After three failed submissions, FDA accepts for review a Fabre-Kramer Pharmaceuticals NDA resubmission for Exxua (gepirone HCl) extended-release table...

Federal Register

Regulatory Review Period Determined for Byfavo

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Acacia Pharmas Byfavo (remimazolam).

Medical Devices

Corrective Recall Asked for Hemodialysis Units

The Service Employees International Union United Healthcare Workers West asks FDA to order five changes to certain Fresenius USA hemodialysis machine...

Marketing

2022 FDA Advertising, Promotion Enforcement Reviewed

Five King & Spalding attorneys review the nine advertising and promotion enforcement letters FDA issued in 2022.

Medical Devices

Tidepool Loop Insulin Dosing App Cleared

FDA clears a Tidepool 510(k) for its Tidepool Loop, an automated insulin dosing app intended for managing Type 1 diabetes in patients aged six years a...

Human Drugs

FDA Backs Status Quo in Orphan Drug Exclusivity

An FDA clarifying notice says the agency will continue to make orphan drug exclusivity decisions based on a drugs specific approved uses/indications a...