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 Finalizes Guidance on Osteoporosis Drug Development

FDA Finalizes Guidance on Osteoporosis Drug Development

FDA_Logo_Black_2016.gif
August 19, 2019

The FDA issued final recommendations for designing nonclinical bone quality studies to support osteoporosis drug and biologic approvals.

The guidance includes general recommendations for study designs and evaluations. For example, the agency advises sponsors to conduct a study in rats and in a larger nonrodent species, such as nonhuman primates, sheep, pigs or dogs.

Sponsors should generally conduct nonclinical studies with a minimum of two doses, including a dose that has an optimal pharmacological effect on bone mass, in addition to a high dose that’s an “adequate multiple” of the optimally effective dose, the agency says.

View today's stories

Pharmaceuticals Regulatory Affairs
  • Related Events

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

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