FDA Related News

Medical Devices

Prometra II Pump Approved for Intrathecal Baclofen

FDA approves a Flowonix Medical PMA for the Prometra II Programmable Pump System for an expanded use with intrathecal baclofen.

Medical Devices

KinetiCor MRI Motion Correction Cleared

FDA clears a KinetiCor 510(k) for the KinetiCor Motion Correction System and its use with Siemens Magnetom Skyra 3T MRI scanner.

Federal Register

Comments Reopened on Animal Drug Compounding

Federal Register notice: FDA reopens the comment period for an 11/20/2019 notice seeking comments on Guidance for Industry #256 Compounding Animal Dr...

Federal Register

Nonclinical Evaluation of Immunotoxicity Guide

Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologi...

Human Drugs

Cabiralizumab Phase 2 Trial Misses Endpoint

Bristol-Myers Squibb says a Phase 2 trial of cabiralizumab in patients with advanced pancreatic cancer did not meet its primary endpoint.

Medical Devices

FDA Late in Removing Mesh Products: Study

University researchers say that FDA was late in ordering mesh implants used in pelvic organ prolapse from the market, possibly due to positive patient...

Collaborative Review of Scientific Pharmacogenetic Info

CDRH and CDER launch a new Web resource to provide the current science on gene-drug associations.

Human Drugs

Baudax Bio NDA for Anjeso Approved

FDA approves a Baudax Bio NDA for Anjeso (meloxicam injection), indicated for managing moderate to severe pain.

Human Drugs

FDA Issues Insulin Transition Final Rule

FDA issues a final rule and other documents in advance of the 3/23 transition of biological products from Federal Food, Drug, and Cosmetic Act approva...

FDA General

FDA Ignoring Fines for Failing to Report Trials: Column

Research into reporting of clinical trials shows that while FDA could have issued fines of more than $4 billion for companies that failed to report tr...