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.
  • Drug Products
    • Books
    • Books Library
    • Events
    • Form 483s
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
  • Device Products
    • Books
    • Books Library
    • Events
    • Form 483s
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Gottlieb Highlights FDA Efforts on Opioids in Senate Testimony

Gottlieb Highlights FDA Efforts on Opioids in Senate Testimony

FDA_Logo_Blue_2016.gif
April 4, 2019

It was a lovefest for outgoing FDA Commissioner Scott Gottlieb as he testified for the last time before the Senate Committee on Appropriations on the FDA’s budget request for fiscal 2020.

Gottlieb featured the agency’s plans for tackling the opioid crisis and said any future opioid drug approvals will need a “new comparative standard.” Any a new opioid should provide “a significant advantage relative to an already approved opioid drug for the same general indication in terms of greater efficacy and safety,” he said, adding that the approval path could mesh with a breakthrough designation or with new designations.

Gottlieb noted that the FDA is requesting $55 million to continue the battle against the opioid crisis, calling it a significant focal point for the agency. He also highlighted efforts to improve opioid labeling and said the agency will require new studies that analyze a drug’s long-term safety when administered for chronic use.

View today's stories

Pharmaceuticals Regulatory Affairs

Upcoming Events

  • 10Jan

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 12Feb

    Increase Compliance, Reduce Risk with Integrated Digital Solutions: Create a Connected System and Streamline...

  • 17Mar

    FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

  • 19Mar

    SOPs and Policies for the 21st Century: Why Less is More

  • 20Apr

    17th Annual Medical Device Quality Congress

Featured Products

  • Biological-risk-eval-and-mngmnt-for-md-130x160

    Biological Risk Evaluation and Management for Medical Devices

  • Gmp-inspection-preparation-checklist-130x160

    GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • 483sonline-logo-430x250

    483sOnline.com Your Personal Pre-inspection Toolkit

  • Globalmarketimage

    International Devices and Diagnostics Monitor

  • Cryolife_logo

    CryoLife’s Thoracoabdominal Stent Graft Receives CE Mark

  • Patentstablabel

    House Judiciary Committee Advances Patent Abuse Legislation

New!

17th Medical Device Quality Congress

Learn More Here
  • 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
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 © 2019. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing