1. FDA Transparency Initiative and Drugs@FDA
Justina A. Molzon
U.S. FDA

2. Why Transparency? Promotes accountability
Provides information to the public about government activities and initiatives
Enhances the work of the agency
Provides timely and useful information

3. What Does Transparency Mean?
Providing information on commonly misunderstood aspects of the agency
Enhanced insight into:
Agency operations
Decision-making process
Maintaining open channels of communication with stakeholders

4. Transparency Task Force
Established June 2009
Goal: to make useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format.

6. 3 Phase Plan Web-Based Resource to Educate Stakeholders
Improving Information Disclosure
Transparency with Regulated Industry

7. FDA BASICS Phase 1 of the Transparency Initiative
Providing fundamentals of each Center and program responsibilities
Opportunity for feedback via and blog
Identifies leaders in Agency

8. FDA-TRACK: Transparency Tool
                                                                                                    
FDA-TRACK - a new agency-wide program performance management
system that monitors over 100 FDA program offices through
key performance measures.
Objectives of FDA-TRACK:
Transparency – how FDA performs its work
Results – with relevance to the agency’s public health mission
Accountability – develop, track, and report performance measures
Credibility - encourages sharing of information about FDA performance
Knowledge - improve operational effectiveness through better collaboration
and sharing of ideas

14. Approval History, Letters, Reviews,
and Related Documents

15. Therapeutic Equivalents

17. Other Important Information from FDA

18. Medication Guide

19. Obrigada Gracias Thank you Merci