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Human Drugs

N-Lorem Foundation Praises FDA ASO Guidance

n-Lorem Foundation says a new FDA guidance on antisense oligonucleotides will help it develop new treatments for nano-rare patients.

Human Drugs

Exceedingly Burdensome: PhRMA to FDA on Reporting Guide

Pharmaceutical Research and Manufacturers of America tells FDA its draft guidance on reporting the amount of listed drugs and biological products woul...

Human Drugs

FDA Petition Answer Nonresponsive: CRN

The Council for Responsible Nutrition says FDA failed to respond to its legal inquiry on the agencys policy shift involving marketing dietary suppleme...

Medical Devices

Multiple Charges Against NC Physician

The Justice Department says a federal grand jury indictment charges a North Carolina doctor with multiple offenses related to Medicare billing for bal...

Medical Devices

FDA Clears VySpan System

FDA clears the VySpine VySpan posterior cervical thoracic system.

Federal Register

Organization Structures at 4 FDA Centers Modified

Federal Register notice: FDA announces that CDER, CBER, CDRH and Center for Tobacco Products have modified their organizational structures.

Medical Devices

FDA Clears Meridian Campylobacter Assay

FDA clears a Meridian Bioscience 510(k) for the Curian Campy assay, a rapid, qualitative fluorescent immunoassay for detecting Campylobacter-specific ...

Marketing

Revised PhRMA Code Now in Effect

Attorney Faraz Siddiqui explains provisions of the revised PhRMA Code on company interactions with healthcare practitioners and why companies may want...

Human Drugs

FDA Lifts Hold on Spero Antibacterial Trial

FDA removes a Spero Therapeutics clinical hold on a Phase 2 trial of SPR720, an investigational oral product being developed for nontuberculous mycoba...

FDA General

FDA Postpones Inspections as Omicron Spreads

FDA says it has temporarily postponed all face-to-face domestic and foreign inspectional work except for mission-critical inspections because of safet...