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 » INTERNATIONAL AGREEMENT WILL NOT EXACERBATE BURDEN ON PERSONALIZED MEDICINE, SAYS FDA

INTERNATIONAL AGREEMENT WILL NOT EXACERBATE BURDEN ON PERSONALIZED MEDICINE, SAYS FDA

May 1, 2006

An international effort between the U.S., the European Union and Japan to standardize industry submission and agency review of genomic data will move personalized medicine forward without increasing regulatory burdens, a high-ranking FDA official says.

The FDA is working with its counterparts in the European Medicines Agency (EMEA) and Japan's Organization of the Ministry of Health, Labor and Welfare (MHLW) to harmonize how regulators assess voluntary genetic data submissions and to clarify what they expect in drug applications when genomic data is involved, Felix Frueh, the agency's associate director for genomics within the Office of Clinical Pharmacology told FDAnews.

But, contrary to some industry concerns, these efforts will not result in greater burdens on industry, he said.

Some industry attorneys are concerned that a joint agreement between the FDA and the EMEA could foreshadow regulators' making genomic data submissions mandatory. But Frueh says this will not happen. "I am absolutely not concerned about this leading to an increase in required submissions," he said. This effort only codifies standard practice that regulators already use in assessing this data, he added.

This statement of principles will formalize the FDA and EMEA's practices for reviewing the voluntary submissions, including timelines for review and how feedback will be submitted to the companies, he said. This approach allows for greater transparency in how regulators review this data and ensures that the reviews are more thorough by establishment of information-sharing protocols.

Putting a formal process in place saves time, money and the burden that companies face by submitting the same information twice, to the FDA and then the EMEA, Frueh said.

The statement of principles should be released within the next few days, once the EMEA officials sign off, he said. The document is just "going through the bureaucracy" of getting the right people to read it. (http://www.fdanews.com/did/5_85/)

KEYWORDS FDAnews Drug Daily Bulletin

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

  • 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

  • Effective text

    Pfizer/BioNTech Vaccine Equally Effective for All Age Groups, Israeli Study Says

  • Siemens Healthineers logo

    Siemens Healthineers’ COVID-19 Antigen Lab Test Receives CE Mark

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