Fda advisory committee for pharmaceutical science and clinical pharmacology july 22 23 2008
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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 Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration. Welcome.

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FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008

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Fda advisory committee for pharmaceutical science and clinical pharmacology july 22 23 2008

FDA Advisory Committee for Pharmaceutical Science and Clinical PharmacologyJuly 22-23, 2008

Introduction and Update

Helen N. Winkle

Director, Office of Pharmaceutical Science

Center for Drug Evaluation and Research

Food and Drug Administration


Welcome

Welcome

  • Ken Morris – chair of advisory committee

  • Returning members and SGEs

  • New members

  • FDA staff

  • Interested participants


What s new in cder

What’s New in CDER?

  • Scientific Challenges and Skepticism

  • Various Initiatives affecting CDER


Exciting and challenging times in ops

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


Initiatives and other activities affecting programs in ops

Initiatives and Other Activities Affecting Programs in OPS

  • Continuing

    • Pharmaceutical Quality for the 21st Century Initiative

    • Critical Path Initiative

    • PDUFA

  • New

    • Science Board Report

    • IOM Report

    • Safety First/ Safe Use

    • FDAAA


General purpose of initiatives and activities as relate to cder

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


Role of advisory committee

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


Agenda 1 st day

Agenda – 1st 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


Agenda day 2

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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