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

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

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

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.

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

FDA BASICS Phase 1 of the Transparency Initiative Providing fundamentals of each Center and program responsibilities Opportunity for feedback via email and blog Identifies leaders in Agency http://www.fda.gov/AboutFDA/Basics/default.htm

FDA-TRACK: Transparency Tool                                                                                                        www.fda.gov 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

Approval History, Letters, Reviews, and Related Documents

Therapeutic Equivalents

Other Important Information from FDA

Medication Guide

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