FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

ICH Good Clinical Practice Guide Comments

The International Council for Harmonization releases for public comment a draft document entitled ICH Harmonized Guideline Good Clinical Practice (GC...

latest-news-card-1
Human Drugs

FDA Seeks Contractors for Drug Performance Automation

FDA asks for proposals to develop artificial intelligence systems to assist it with drug product imaging and analysis.

Human Drugs

Digital Medicine Society Praises FDA Help

The Digital Medicine Society praises FDA for its work in addressing using digital health technologies in drug and biological product development.

latest-news-card-1
Human Drugs

FDA Warns India Pharmacy Over Unapproved Drugs

FDA warns Gujarat, India-based Champaklal Maganlal Homeo Pharmacy Private Limited and two New Castle, DE-based companies that they are distributing tw...

latest-news-card-1
Medical Devices

SD Biosensor Recalls Contaminated Covid Tests

SD Biosensor recalls its Pilot Covid-19 At-Home Test due to microbial contamination.

latest-news-card-1

Call Out Lawyer Client-Seeking Ads: Petition

A University of Florida law professor calls on FDA to define personal injury attorney client-seeking ads that cross a line and may harm patients using...

latest-news-card-1
Human Drugs

Safety Alert on Pediatric Cough Drops

FDA issues a safety alert on Novis-branded over-the-counter G-Supress DX Pediatric Drops because they may contain the incorrect product and cause pati...

latest-news-card-1
Federal Register

Regulatory Review Period Corrected for Enspryng

Federal Register notice: FDA corrects a 7/13/2022 notice that announced the regulatory review period determination for Genentechs Enspryng (satralizum...

latest-news-card-1
Human Drugs

Ex-FDAer Schiller on Accelerated Approval Guide

Aetion chief legal/regulatory officer and former FDA associate commissioner for policy Lowell Schiller says the agency should address the use of exter...