Welcome and Introduction to the Meeting

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Welcome and Introduction to the Meeting. Ajaz S. Hussain, Ph.D. Office of Pharmaceutical Sciences CDER, FDA October 21, 2003. 2003 Accomplishments Office of Pharmaceutical Science. PAT – Process Analytical Technology Research – Rapid Response: ketamine, KI, doxycycline Pharmacogenomics
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Welcome and Introduction to the MeetingAjaz S. Hussain, Ph.D.Office of Pharmaceutical SciencesCDER, FDAOctober 21, 20032003 Accomplishments Office of Pharmaceutical Science
  • PAT – Process Analytical Technology
  • Research – Rapid Response: ketamine, KI, doxycycline
  • Pharmacogenomics
  • ONDC – Acting Director, Dr. Moheb Nasr
  • New Office of Biotechnology Products – Acting Director, Dr. Yuan-Yuan Chiu
  • State of CDER 2003 State of CDER 2003 Office of Generic DrugsState of CDER 2003 Office of Generic DrugsState of CDER 2003 Commissioner’s Innovation Initiative
  • Response to falling NME application rates observed world-wide (not unique to FDA)
  • Overall goal: help streamline/facilitate drug development (NOT shorten review times)
  • Root cause analysis – multiple cycles
  • Additional guidances – e.g. pharmacogenomics
  • Quality systems principles in review process
  • State of CDER 2003 FDA’s Product Quality for the 21st Century Initiative
  • Two year effort, half way through
  • Major accomplishments:
  • Pharmaceutical Inspectorate in field
  • Final Guidance on Part 11
  • PAT draft guidance
  • ’04 Plans
  • Finish what is started
  • Work on internal quality system
  • ICH and other international harmonization
  • State of CDER 2003 Wrap-Up
  • 2003 : Record of accomplishments and strengthening of CDER
  • 2004 brings:
  • Administrative uncertainties
  • Scientific challenges
  • Expectations of continued high performance AND improvements
  • State of CDER 2003 Pharmaceutical cGMP Initiative: Progress as of September ‘03
  • Part 11, Electronic Records, Electronic Signatures - Scope and Application (final guidance)
  • Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (draft guidance)
  • Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practices (draft guidance)
  • Comparability Protocols - Protein Drug Products and Biological Products, Chemistry, Manufacturing, and Controls Information (draft guidance)
  • PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (draft guidance)
  • Pharmaceutical cGMP Initiative: Progress as of September ‘03
  • Cooperative Research and Development Agreement (CRADA) with Pfizer, Inc.
  • Collaboration with the McDonough School of Business at Georgetown University, Washington, DC, and the Olin School of Business at the Washington University, St. Louis.
  • Collaboration with the National Science Foundation's Center for Pharmaceutical Processing Research
  • This Meeting
  • Subcommittee reports
  • Draft PAT Guidance report
  • PTIT proposal for DCU
  • Risk Based CMC Review
  • Nomenclature challenges
  • Generic research program
  • Search Related
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