Food and Drug Administration

Science Board to the Food and Drug Administration

November 5, 2004

Briefing Information

Innovation and Continuous Improvement in Pharmaceutical Manufacturing - Pharmaceutical CGMPs for the 21st Century (PDF)

Pharmaceutical CGMPs for the 21st Century - A Risk-Based Approach, Final Report (PDF)

Report of the ORA Science Peer Review Committee on the FDA Pesticides Program (HTM) (PDF) (Word)

Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites - A Pilot Risk Ranking Model (PDF)

Stimulating Medical Innovation - HHH Task Force, Dr. Larry Kessler, ScD, FDA (HTM) (PPT)

Final Report on Process Analytical Technology (PAT) and Manufacturing Science, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

CDER Risk-Based Site Selection Model: An FDA Risk Management Tool, Dr. Kara Morgan, FDA (HTM) (PPT)

Pesticide and Industrial Chemical Programs, Dr. Marzilli, FDA (HTM) (PPT)

Critical Path Public Docket: Overview for the FDA Science Board, Dr. Rovin, FDA (HTM) (PPT)

"Critical Path" for Food and Nutrition, Alan Rulis (HTM) (PPT)

Critical Path Research: Getting New Technology From Bench to Bedside - A Device Perspective, Dan Schultz, FDA (HTM) (PPT)

CDER Critical Path Opportunities, Dr. Douglas Throckmorton, MD, FDA (HTM) (PPT)

Report on "Pharmaceutical GMPs for the 21st Century" Initiative, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)

Current Plan for Critical Path Initiative, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)