We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs, Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
About FDAnewsOur Top-rated ProductsLatest NewsConferences and WebinarsFDAnews In Your InboxBooks and Managment ReportsLatest Offering

FDAnews About Logo

Open a new line of discovery and insight.

Learn More

483s Online

More than 7,200 Available

Search our ever-expanding database of Form 483 reports all downloadable at the click of a button.
Search

FDAnews About Logo

We're here to help simplify global compliance.

Learn More

Our Top-Rated Products

View All →
  • DrugDeviceClinical
    Risks of Social Media Communication

    Risks of Social Media Communication: A Guide to FDA and FTC Enforcement

    Learn More
  • DrugDeviceClinical
    Recall Readiness: Preparing to Meet FDA Requirements

    Recall Readiness: Preparing to Meet FDA Requirements

    Learn More
  • DrugDeviceClinical
    Risk Management in Clinical Trials

    Risk Management in Clinical Trials: The New ICH E6 Focus

    Learn More
Medical Device Information
Pharmaceutical Information

Conferences and Webinars

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

View All →

FDAnews Webinar Training Pass

The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars we run each year. These training programs feature top consultants, expert speakers and FDA officials.
Learn More

FDAnews In Your Inbox

FDAnews In Your Inbox

Keep track of global regulatory, legislative and business news developments in the industry.

Drug Daily Bulletin

Receive news briefs for the pharmaceutical and biologics industries. In just a few minutes you can scan major headlines and know what you need to know for the day.
Learn More →

Device Daily Bulletin

Keep track of important global regulatory, legislative and business news developments in the medical device industry. Sign up now and receive FDAnews Device Daily Bulletin the next business day.
Learn More →

Books and Management Reports

  • FDA’s Alternative Inspection Tools

    FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

    Learn More
  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

    Learn More
  • Supply Chain Solutions: Managing Demand and Logistics in a Postpandemic World

    Supply-Chain Solutions: Managing Demand and Logistics in a Postpandemic World

    Learn More
View All →
Books library banner

FDAnews Online Books Library Subscription

Year-round unrestricted access to all books and reports. They can be accessed, searched, downloaded and read on laptops and other mobile devices anywhere, anytime.
Learn More →

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Prepare for ICH E8(R1) now.
Be ready before June!

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing