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FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008 Introduction and Update Helen N. Winkle Director, Office of.

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Presentation on theme: "FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008 Introduction and Update Helen N. Winkle Director, Office of."— Presentation transcript:

1 FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008 Introduction and Update Helen N. Winkle Director, Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration

2 Welcome Ken Morris – chair of advisory committee Returning members and SGEs New members FDA staff Interested participants

3 What’s New in CDER? Scientific Challenges and Skepticism Various Initiatives affecting CDER

4 Exciting and Challenging Times in OPS Made progress Implemented concepts to improve quality – new CMC review paradigm (QbD) Modernized our science base for generic drug approval Improved capability to meet the demand for generic drugs International harmonization But… More post approval actions required Vulnerabilities in drug safety program Growing skepticism about generic drugs Still determining if science sufficient to have follow-on biologics Must deal with new dosage forms and new technologies Need for adequate training to meet growing requirements and changing processes

5 Initiatives and Other Activities Affecting Programs in OPS Continuing Pharmaceutical Quality for the 21 st Century Initiative Critical Path Initiative PDUFA New Science Board Report IOM Report Safety First/ Safe Use FDAAA

6 General Purpose of Initiatives and Activities as Relate to CDER Ensure adequate scientific support for ensuring safety, efficacy and quality of marketed products Provide scientific and technical methods to improve predictability and efficiency to better develop and manufacture drug products Facilitate adoption of quality management techniques in regulatory processes Implement risk-based approaches to product regulation Enhance postmarket authorities to better ensure product safety – maintain focus on drugs once they are on the market Improve upon professional culture Prepare scientific and regulatory processes for future – including understanding new technologies and preparing for different ways of developing drugs (e.g., novel dosage forms) Ensure adequate resources

7 Role of Advisory Committee Advisory committee purpose is basically to promote a better FDA and industry understanding of the unique challenges in the present and future healthcare environment Committee’s role is to provide scientific advice in order to help FDA in responding to these challenges Science Board Report of 2007: “…science at FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current emerging regulatory responsibilities.” Collaboration necessary through advisory committee is a must

8 Agenda – 1 st Day Nanotechnology Brought before committee before as an awareness topic Issued Agency report in Fall 2007 – need for regulation throughout FDA Still need to determine how best to regulate in CDER and what we need to focus on to ensure safety of products containing nanoparticles Lead in Pharmaceutical Products National focus on all products containing lead Ensuring focus on pharmaceutical products as well – need to be prepared and informed Need to ensure appropriate regulatory framework

9 Agenda – Day 2 Bioequivalence for Locally Acting Drugs that Treat Gastrointestinal Conditions Need to ensure using most scientific bioequivalence methodology Drug Classification of Orally Disintegrating Tablets Nomenclature and consistency issue Use of Inhaled Corticosteriod Dose Reponses as a Means to Establish Bioequivalence of Inhalation Drug Products Need to ensure using most scientific bioequivalence methodology


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