FDA Related News

Medical Devices

Better Implantable Device Testing Needed: Wolfe

Public Citizens Sidney Wolfe tells the FDA General and Plastic Surgery Devices Panel that FDA should require extensive pre-approval testing of permane...

Human Drugs

InControl Medical OTC Incontinence Device Cleared

FDA clears an InControl Medical 510(k) for the Attain, an over-the-counter non-implantable muscle stimulator designed for at-home use to help treat wo...

Medical Devices

Masimo CO-Oximeter Cleared by FDA

FDA clears a Masimo 510(k) for the Rad-67 Pulse CO-Oximeter with Spot-check Next Generation SpHb monitoring technology and the rainbow DCI-mini Reusab...

Human Drugs

Praise for FDA Patient Experience Draft Guidance Draft

Stakeholders praise FDA for a draft guidance on how patient advocacy groups may submit their own proposed draft guidances to make use of patient exper...

Human Drugs

Mariposa Labs CGMP Violations

FDA warns Mariposa Labs about CGMP and other violations in its production of finished pharmaceuticals.

Human Drugs

CDER Working on Pharmacokinetic Modeling

CDER clinical pharmacologists say they are working with stakeholders to develop computational models to achieve safe and effective dosing recommendati...

Human Drugs

Celgene NDA Filed for MS Drug Ozanimod

Celgene submits an NDA for ozanimod for treating adults with relapsing forms of multiple sclerosis.

Medical Devices

FDA Steps to Prevent Medical Device Shortages

FDA commissioner Scott Gottlieb discusses steps the agency is taking to help medical device patients cope with potential shortages due to closure of s...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Mariposa Labs and Thibiant International.

Guide on Using Standards for CBER Submissions

FDA posts a final guidance on Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation...