The Future of Drug Safety Promoting and Protecting the Health of the Public (2007) / Chapter Skim
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Appendix A Moving Target--The Shifting Landscape of Drug Safety in the United States
Appendix A Moving Target--The Shifting Landscape of Drug Safety in the United States
Pages 205-216
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to help FDA realize its vision of culture of openness, enhanced oversight, and transparency in decision making. The DSB is charged with identifying, tracking, and overseeing the management of important drug safety issues in the Center for Drug Evaluation and Research (CDER)
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STRUCTURAL CHANGES AND LEADERSHIP CHANGES IN THE CENTER FOR DRUG EVALUATION AND RESEARCH In September 2004, CDER announced that it would be restructuring the Office of New Drugs (OND) and has implemented this in phases throughout 2005–2006 (FDA and CDER, 2005)
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LEADERSHIP CHANGES IN THE FOOD AND DRUG ADMINISTRATION Over the course of this study, several changes in leadership have taken place in FDA. When the study began, Lester M
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RECENT MATERIALS FROM THE FOOD AND DRUG ADMINISTRATION Guidance Documents In March 2005, FDA released three final guidance documents to help develop new ways to improve methods of assessing and monitoring risks associated with drugs in clinical development: • Guidance for Industry: Premarketing Risk Assessment (FDA et al., 2005)
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. Deficiencies in safety assessment during the Investigational New Drug process were cited in the report as a main cause of multiple review cycles, which potentially could have been avoided if a "milestone meeting" had taken place where CDER staff could have made suggestions for improving the quality of the initial applications (FDA News, 2006c)
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0 THE FUTURE OF DRUG SAFETY OTHER RELEVANT CHANGES AT THE FOOD AND DRUG ADMINISTRATION AND THE CENTER FOR DRUG EVALUATION AND RESEARCH Labeling On November 2, 2005, FDA started requiring that drug manufacturers submit prescription drug label information to FDA in a new electronic format. That was intended to allow patients and healthcare providers to obtain information in FDA-approved package inserts ("labels")
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APPENDIX A PROGRAM REVIEWS OR EVALUATIONS Advisory Committees In May 2006, CDER announced that it was launching an internal assessment of its Advisory Committee meeting system to establish best practices surrounding that process. The assessment will be led by senior management in CDER and will take a comprehensive look at current practices for nominating committee members, screening for conflicts of interest, choosing expertise for specific meeting topics, and utilizing Special Government Employees.
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One related to safety is the use of biomarkers to predict the performance of a product during development and thus reduce uncertainties about safety or effectiveness. If the biomarkers can be identified, validated, and shown to improve health outcomes, FDA believes that these priorities "will increase efficiency, predictability, and productivity of new medical products" (FDA, 2004, 2006b)
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. CDER (Center for Drug Evaluation and Research)
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. FDA (Food and Drug Administration)
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2005. FDA Issues Final Risk Management Guidance's.
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