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• Major accomplishments:– Pharmaceutical Inspectorate in field– Final Guidance on Part 11– PAT draft guidance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