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 SOLICITS DNA STUDY DATA TO DEVELOP BIOMARKERS

FDA SOLICITS DNA STUDY DATA TO DEVELOP BIOMARKERS

April 28, 2006

The FDA is soliciting data from deoxyribonucleic acid (DNA) studies and seeking proposals to analyze this data to further the agency's development of biomarkers, a recent Federal Register notice says. Submissions are due by May 31.

The FDA wants to determine the best way to develop biomarkers as part of its effort to promote personalized medicine under the Critical Path initiative. Personalized medicines are developed to treat certain subsets of the population based on their particular genetic makeup. These new medicines are considered by both the FDA and industry to be the wave of the future, taking the place of traditional treatments. Biomarkers are indicators of normal biological processes that show how well a particular treatment will work.

However, before such medicines can be developed, the agency needs to analyze how DNA microarray data is assessed to ensure the data is reliable, the notice says. A microarray is a tool for analyzing gene expression. It consists of a small membrane or glass slide containing samples of many genes arranged in a regular pattern. DNA microarray is a collection of microscopic DNA spots attached to a solid surface, such as glass, plastic or silicon chip forming an array.

The notice is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/nctr061-n000001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/nctr061-n000001.pdf).

KEYWORDS FDAnews Drug Daily Bulletin

Upcoming Events

  • 21Apr

    CDER’s Most Significant Guidance Priorities for 2021: Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

  • 12May

    Extractables and Leachables: 101

  • 25May

    How Can the Accelerated Availability of Pfizer-BioNTech’s COVID-19 Vaccine be Replicated?

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • EMA logo European Medicines Agency logo

    EMA Reviews GSK’s and Vir’s VIR-7831 for COVID-19

  • CE mark

    Hensler Surgical Technologies Earns CE Mark for Bone-Fusion Device

  • Eli lilly logo

    Eli Lilly Asks FDA to Nix EUA for Bamlanivimab Alone

  • CE mark

    Alimetry Earns CE Mark for Wearable Gastric Disease Diagnostic

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