Food and Drug Administration

Science Board

November 16, 2001


Emerging Science Issues:  Pharmaceutical Manufacturing

FDA Regulation of Drug Quality:  New Challenges, Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA   ppt   htm

Productivity and the Economics of Regulatory Compliance in Pharmaceutical, Doug Dean & Frances Bruttin, PwC Consulting Pharmaceutical Section Team   ppt   htm

Pharmaceutical manufacturing: New Technology Opportunities., G K Raju, PhD, Pharmaceutical Manufacturing Initiative (PHARMI), MIT Program on the Pharmaceutical Industry, Maassachusetts Institute of Technology   ppt   htm

An Industry Perspective on the Potential for Emerging Process Analytical Technologies, Norman Winskill, Steve Hammond, Pfizer Global Manufacturing Services   ppt   htm

Open Public Comment

Pharmaceutical production -- Batch Processes, Nouna Kettaneh-Wold   ppt   htm

Enhancing Regulatory Science Animal Research, Gideon Kantor, PhD   pdf   htm   doc

Prudent Policy-Making and Health Communication Amidst Scientific Uncertainty, Scott G Ratzan, MD, MPA, MA, Yale University School of Medicine, Tufts University School of Medicine, George Washington University School of Public Health and Health Sciences   ppt  htm

Gabi Levin, PhD, Brimrose,   ppt   htm

TQMS, Statistically Based In-Process control with Real Time Quality Assurance, The AstraZeneca Total Quality Management Strategy, R S Chisholm, International Technology Manager  ppt   htm

Update on CDRH External Science Review

Science at Work in CDRH: The Role of Science in the Regulatory Process, Robert M Nerem, PhD   pdf   htm   doc

Response to Update

CDRH Science Review: Center Perspectives, David W Feigal, MD, MPH, Director, Center for Devices and Radiological Health, FDA   ppt  htm

Emerging Issues in FDA's Oversight of Clinical Research

Emerging Issues in FDA's Oversight of Clinical Research, David A Lepay, MD, PhD, FDA   ppt   htm