FDA Related News

Medical Devices

NeuroOne Medical 510(k) for Ablation System

NeuroOne Medical Technologies files a 510(k) for its OneRF Ablation System.

Medical Devices

Device Software Submission Guidance

FDA publishes a guidance on recommended content of premarket submissions for software contained in medical devices.

Human Drugs

A&Z Selling Illegal New Kids Drug

FDA warns Hauppauge, NY-based A&Z Pharmaceutical about illegally marketing an unapproved childrens calcium drug.

Recorlev Web Pages False or Misleading: FDA

The CDER Office of Prescription Drug Promotion says Xeris Web pages for Recorlev create a misleading impression about the drugs efficacy and safety.

Human Drugs

FDA Rare Disease ARC Program Update

CDER associate director for rare diseases Kerry Jo Lee highlights the one-year successes of the Accelerating Rare disease Cure program and looks to th...

Medical Devices

GE HealthCare Update on Neonatal Incubators

An FDA update says GE HealthCare has conducted preliminary testing on its newly manufactured neonatal incubators that suggests the potential for highe...

Medical Devices

OTC Erectile Dysfunction Gel Authorized in U.S.

FDA grants Futura Medical a de novo marketing authorization for over-the-counter MED3000, a topical gel formulation for treating erectile dysfunction.

Federal Register

Moran Debarred for Five Years

Federal Register notice: FDA issues an order to debar Luis Anarbol Moran for five years from importing any drug into the U.S.

Federal Register

Info Collection on Orphan Drugs

Federal Register notice: FDA seeks comments on an information collection extension entitled Orphan Drugs 21 CFR Part 316.

FDA General

BIO on FDA Data, Technology Plan

BIO suggests revisions to an FDA strategic plan for modernizing the agencys data and technology systems.