Food and Drug Administration

Advisory Committee for Pharmaceutical Science

November 28, 2001

Briefing Information

Introduction   [pdf version] [htm version] [Word version]

 Index and Bibliography [pdf version]

Federal Register Notice of Meeting [66FR53225 10/19/01)  [pdf version] [text version]

Guidance for Industry ANDAs:  Blend Uniformity Analysis, Draft Guidance, August 3, 1999 [pdf version]

Additional Briefing Information (New 11/27/01)

FDA Regulation of Drug Quality:  New Challenges, Janet Woodcock, MD, FDA   [ppt version] [htm version] [pdf version]

Emerging Science Issues in Pharmaceutical Manufacturing:  Process Analytical Technologies, Ajaz S Hussain, PhD, FDA   [ppt version] [htm version] [pdf version]

Pharmaceutical Manufacturing: New Technology Opportunities.., G K Raju, PhD, Massachusetts Institute of Technology   [ppt version] [htm version] [pdf version]

Productivity and the Economics of Regulatory Compliance in Pharmaceutical Production, Doug Dean & Frances Bruttin, PwC Consulting   [ppt version] [htm version] [pdf version]

An Industry Perspective on the Potential for emerging Process Analytical Technologies, Norman Winskill & Steve Hammond, Pfizer Global Manufacturing Services  [ppt version] [htm version] [pdf version]