FDA Related News

Medical Devices

Arthrosurface Toe Fixation Cleared by FDA

FDA clears an Arthrosurface 510(k) for its BOSS Toe Fixation System for stabilizing the first metatarsal that presents with a distal bone void.

Combination Product Labeling Contents

Three stakeholders suggest changes to an FDA draft guidance on instructions for use in combination product labeling.

Human Drugs

Too Few Antibiotics in Development: Pew Report

A Pew Charitable Trusts issue brief says there are not enough new antibiotics in the development pipeline to meet the need.

Federal Register

Info Collection Extension for PET Drug GMPs

Federal Register notice: FDA has submitted to OMB an information collection extension for positron emission tomography Drug GMPs.

FDA General

Sharpless Supporters More Vocal

Supporters of FDA acting commissioner Ned Sharpless urge the administration to nominate him as permanent commissioner.

Federal Register

Panel to Discuss Duodenoscope Sterilization

Federal Register notice: FDA announces an 11/6-7 Advisory Committee meeting to discuss industrial ethylene oxide sterilization of medical devices, inc...

Human Drugs

Chromatographic Bioanalysis Guidance

FDA issues a guidance to make recommendations to sponsors, applicants, and contract research organizations on internal standard response variability i...

Human Drugs

Ex-FDAer Sherman Joins Aptinyx Board

Former FDA principal deputy commissioner Rachel Sherman joins Aptinyxs board of directors.

Human Drugs

Pediatric Labeling Changes for Sovaldi and Harvoni

FDA summarizes labeling changes to Gileads Solvadi and Harvoni to add pediatric dosage forms.

Human Drugs

FDA Warnings Yield Lower Chantix Use: Study

Researchers say early FDA drug safety communications on Pfizers Chantix led to reduced prescribing in the VA health system, leading to an estimated 45...