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 Scraps Suffixes for Older Biologics’ Proper Names

FDA Scraps Suffixes for Older Biologics’ Proper Names

FDA_Logo_Blue_2016.gif
March 13, 2019

The FDA has decided not to require four-letter suffixes for already-approved or licensed biological products with no FDA-designated suffix in their proper names.

The agency issued draft guidance in January 2017 seeking to add a unique four-letter suffix to the proper names — also called “nonproprietary names” — of biological products, including originator products and biological products already on the market. But the proposal drew pushback from drugmakers who expressed concern that adding suffixes to older biologics’ names could confuse patients.

In a draft guidance, the agency explained that it considers it unnecessary to change the proper names of biological products that have already received licensing or approval and that lack an FDA-designated suffix. “The core objectives of the naming convention — pharmacovigilance and safe use — can be accomplished by applying the naming convention to biological products at the time they are licensed … and without applying it to licensed biological products that do not contain a suffix in their proper names,” the agency said.

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

  • Sanofi-Regeneron_Logos.png

    Sanofi’s and Regeneron’s Libtayo Wins FDA Approval for NSCLC

  • PerkinElmer logo

    PerkinElmer’s Rapid Point-of-Care COVID-19 Test Cleared in Europe

  • WhiteHouse.gif

    President Biden Issues Executive Order on U.S. Supply Chain

  • roche.gif

    Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million

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