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 » Generics Will Find it Harder to Implement REMS Reforms, AAM Says

Generics Will Find it Harder to Implement REMS Reforms, AAM Says

April 10, 2019

The FDA’s proposed guidance on Risk Evaluation Mitigation Strategies (REMS) will be much easier for brand-name drugmakers to implement than for generic manufacturers, the Association for Accessible Medicines said.

Sharing of safety data “can get very complex when the data has to be pooled among multiple sponsors within a class of products,” AAM said in a written comment on a draft REMS assessment guidance the agency issued in January.

As an example, the association pointed to the REMS for transmucosal immediate-release fentanyl. “One way the sponsors were able to mitigate data pooling issues was to list adverse events by product type rather than by product-specific basis,” AAM said, calling for agency guidance on how this type of data should be broken down in a way that will be useful for the agency but not overly burdensome to sponsors.

View today's stories

Pharmaceuticals Regulatory Affairs

Upcoming Events

  • 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

  • 07Mar

    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

  • 08Mar

    Medical Device Cybersecurity: The Regulatory Landscape and How to Defend Your Practices During an Inspection

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

  • Boston Scientific’s Single Use Ureteroscope Gets FDA Clearance

  • Gilead’s Trodelvy Gets Expanded Approval in Breast Cancer

  • AI Software to Improve Echocardiogram Images Gets FDA Clearance

  • Rocket Pharmaceuticals Gets RMAT Designation for Danon Disease Gene Therapy

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