Food and Drug Administration

Advisory Committee for Pharmaceutical Science

October 19, 2004


Introduction and Welcome, Dr. Winkle (HTM) (PPT)

Meeting Dates and Topics, Dr. Judy Boehlert, PhD (HTM) (PPT)

Update on Our Process to Address Specifications for Delivered Dose Uniformity of Inhaled and Nasal Drug Products, Dr. Robert O'Neill, PhD (HTM) (PPT)

Critical Path Initiative: Challenges and Opportunities, Dr. Ajaz Hussain, PhD (HTM) (PPT)

Strategic Critical Path Research, Dr. Keith Webber, PhD (HTM) (PPT)

Development and Application of Computational Toxicology and Informatics Resources at the FDA CDER Office of Pharmaceutical Science, Dr. Joseph Contrera, PhD, et. al. (HTM) (PPT)

Critical Path Initiative ONDC Perspective, Dr. John Simmons, PhD, FDA (HTM) (PPT)

FDA's Critical Path to Medical Product Development: Opportunites for Generic Drugs, Dr. Lawrence Yu, PhD, FDA (HTM) (PPT)

The Critical Path Initiative: The Division of Therapeutic Proteins' Perspective, Dr. Amy Rosenberg, MD, FDA (HTM) (PPT)

Division of Monoclonal Antibodies Overview, Steven Kozlowski, FDA (HTM) (PPT)

Critical Path Intiative and Lab-Based Bio-Research (Small Molecules), Dr. Jerry Collins, PhD, FDA (HTM) (PPT)

Research in Support of the Critical Path Dimensions, Dr. Lucinda Buhse, PhD, FDA (HTM) (PPT)

DPQR: Advancing "Critical Path" Research, Dr. Mansoor Khan, RPh, PhD, FDA (HTM) (PPT)

Implications and Challenges, Vincent Lee, FDA (HTM) (PPT)

Questions (HTM) (PPT)

Open Public Hearing

Electronic Diaries: Impact on Drug Development, Dr. Saul Shiffman, PhD, Invivodata, Inc. (HTM) (PPT)