FDA Releases New Guidance on Drug Development Tools - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Releases New Guidance on Drug Development Tools


FDA has released guidance on the process for qualifying drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. Guidance for Industry and FDA Staff, Qualification Process for Drug Development Tools defines DDTs as methods, materials, or measures that aid drug development that include, but are not limited to, biomarkers, clinical outcome assessments (COAs), and animal models for drug development under the Animal Rule.

FDA provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the submitter of the DDT for qualification. The guidance outlines the kinds of data that should be submitted to support qualification of a DDT. It also creates a process for CDER’s formal review of the data.

The guidance states, “Qualification does not pertain to the process for review of DDTs that are submitted as part of regulatory applications for a specific drug development program. Furthermore, this guidance does not address the evidentiary standards or performance requirements needed for purposes of qualification.”

FDA also released an attachment to the guidance on the qualification of exacerbations of chronic pulmonary disease tool.

Source: FDA.gov

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here