1. Ajaz S. Hussain, Ph.D. Office of Pharmaceutical Sciences CDER, FDA October 21, 2003 Welcome and Introduction to the Meeting

2. 2003 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

3. Office of Generic Drugs State of CDER 2003

4. Office of Generic Drugs State of CDER 2003

6. 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

7. FDA’s Product Quality for the 21 st 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effort, half way through Major accomplishments: –Pharmaceutical Inspectorate in field –Final Guidance on Part 11 –PAT draft guidance ’04 Plans –Finish what is started –Work on internal quality system –ICH and other international harmonization State of CDER 2003

8. 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

9. 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Application (final guidance) Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (draft guidance) Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practices (draft guidance) Comparability Protocols - Protein Drug Products and Biological Products, Chemistry, Manufacturing, and Controls Information (draft guidance) PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (draft guidance)

10. 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

11. This Meeting Subcommittee reports Draft PAT Guidance report PTIT proposal for DCU Risk Based CMC Review Nomenclature challenges Generic research program