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 & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Schedules Public Hearing on Insulin Biosimilars

FDA Schedules Public Hearing on Insulin Biosimilars

April 9, 2019

The FDA will hold a May 13 public hearing to discuss ways to improve the efficiency of biosimilar insulin development.

Former FDA Commissioner Scott Gottlieb said the transition of insulin from the drug to the biologics pathway “will open up these products to biosimilar competition.” The agency is already seeing “robust activity among sponsors seeking to bring forward biosimilar copies of insulin,” he said.

Participants planning to present at the hearing must register by April 29. Those who wish to merely attend or speak at the event must register by May 9, the agency said.

View today's stories

Pharmaceuticals Regulatory Affairs

Upcoming Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • NeuroMetrix Launches DPNCheck 2.0 for Peripheral Neuropathy Screening

  • Syros Gets Fast Track Status for Higher-Risk Myelodysplastic Syndrome Candidate

  • FDA Approves Abbott’s Spinal Cord Stimulation System for Diabetic Peripheral Neuropathy

  • FDA Expands Approval for Merck’s Keytruda in NSCLC

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 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