About FDA

Pharmaceuticals Users Software Exchange (PhUSE)

PhUSE Collaborations

The Pharmaceutical Users Software Exchange (PhUSE) Computational Science Collaborations provide a platform for academia, regulators, industry, and technology providers to address computational science needs in support of regulatory review. The first annual Computational Science Symposium (CSS) in 2012 was co-sponsored by PhUSE, the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER). Since then, participants from multiple FDA centers have contributed to many ongoing PhUSE Computational Science Collaborations, resulting in the development of resources that improve preparation and analysis of regulatory data and associated documentation. As described in table 1 below some of these resources have been referenced in FDA documentation.

FDA participants follow the guidelines set forth in the MAPP 4100.2: CDER Staff Participation in Public Private Partnerships and Consortia. This MAPP facilitates consistency and continuity for those engaged in Public Private Partnerships (PPPs) and consortia. Additionally, the process outlined in the graphic below describes a process by which FDA can evaluate and incorporate deliverables into FDA Documentation in compliance with Good Guidance Practices (GGPs).

DELIVERABLE EVALUATION PROCESS

Deliverable Evaluation Process

Table 1.

FDA Review of PhUSE Deliverables

 

PhUSE Deliverable Completion

Step 1: FR Notice

Step 2: FDA Review

Step 3: Updated Documentation

Name

Status

Date

Status

Date
Published

Status

Date
Completed

Document

Version
Date

Study Data Reviewer’s Guide (SDRG)

Completed

26-Jan-15

Completed

23-Jul-16

Completed

1-Oct-16

Technical Conformance Guide

Oct-17

Nonclinical Study Data Reviewer’s Guide (NSDRG)

Completed

3-Mar-16

Completed

4-Mar-16

Completed

10-Nov-16

Technical Conformance Guide

Oct-17

Study Data Standardization Plan (SDSP)

Completed

30-Mar-16

Completed

8-Nov-16

Completed

30-Aug-17

Technical Conformance Guide

Oct-17

Analysis Data Reviewer’s Guide (ADRG)

Completed

26-Jan-15

Completed

8-Dec-16

 

 

 

 

Inspection Site Selection Standard Data Elements

Completed

 May-16

 

 

 

 

 

 

Analysis and Displays Associated with Adverse Events

Completed

 03-Feb-17

 

 

 

 

 

 

Legacy Data Conversion Plan (LDCP)

 

 

 

 

 

 

 

 

For more information contact Office of Computational Science.

Page Last Updated: 03/26/2018
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