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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Issues Final Rule on Electronic Registration

FDA Issues Final Rule on Electronic Registration

August 31, 2016

The FDA has finalized a rule that will require pharmaceutical companies to electronically submit, list and register information on finished drug products and active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients.

The rule is an effort to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and the agency alike.

In addition, the rule supports the implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.

The FDA estimates the one-time total costs of the electronic register will be around $59.7 million. The largest cost elements will be for registrants reading and understanding the final rule and making changes to their standard operating procedures.

View today's stories

Pharmaceuticals Regulatory Affairs

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • UKflag.jpg

    UK Study Says Single Shot of Pfizer/BioNTech Vaccine Significantly Lessened Asymptomatic Infections

  • emergency use authorization approved

    Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test

  • FDA clears text

    Vetex Medical’s Thrombectomy Catheter Cleared by FDA

  • 100Bills_flatmoney.gif

    Merck Purchases Rights to Debiopharm’s Xevinapant for More Than $1 Billion

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

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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing