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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 - PowerPoint PPT Presentation
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Ajaz S. Hussain, Ph.D.Office of Pharmaceutical Sciences
CDER, FDAOctober 21, 2003
Welcome and Introduction to the
Meeting
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 2003State of CDER 2003
Approvals and Tentative Approvals of ANDAs
256
230
198
232241
29650
19
68
6269
68
264
85
0
50
100
150
200
250
300
350
400
1997 1998 1999 2000 2001 2002 2003
Fiscal Year
Nu
mb
er
of
Ap
pli
cati
on
s
Tentative Approvals
Full Approvals
Projected End of FY Totalsas of July 2003
Office of Generic DrugsState of CDER 2003State of CDER 2003
GPRA Measure - % Originals Acted Upon < 180 Days
84% 84%82%
86% 87% 87%84% 84%
83%80%
76%74%
77% 78%80%
87%
93% 93% 94% 95% 96%94% 93%
0%
20%
40%
60%
80%
100%
120%
10/00-03/01
11/00-04/01
12/00-05/01
01/01-06/01
02/01-07/01
03/01-08/01
04/01-09/01
05/01-10/01
06/01-11/01
07/01-12/01
08/01-01/02
09/01-02/02
10/01-03/02
11/01-04/02
12/01-05/02
01/01-06/02
02/02-07/02
03/02-08/02
04/02-09/02
05/02-10/02
06/02-11/02
07/02-12/02
08/02-01/03
Reporting Dates
6 Month Reporting IncrementsReporting Date: July 2003
Office of Generic DrugsOffice of Generic DrugsState of CDER 2003State of CDER 2003
State of CDER 2003State 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 2003State 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• Major accomplishments:– Pharmaceutical Inspectorate in field– Final Guidance on Part 11– PAT draft guidance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 2003State 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 2003State 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