Food and Drug Administration

Pharmaceutical Science Advisory Committee

October 21, 2002

Briefing Information

Cover memo, Dr. Ajaz Hussain, PhD, FDA  HTM  PDF  Word 

Topic: Risk-Based CMC Review, Attachment #1 PDF  Word  Text

Topic: Blend Uniformity, Attachment #2 HTM  PDF  Word

Critique of the PQRI Blend Uniformity Work Group, R. Hollenbeck, U. of Maryland  HTM  PDF  Word

Topic: Polymorphism, Attachment #3 HTM  PDF  Word

Topic: Pharmaceutical cGMPs, Attachment #4  HTM  PDF  Word

Sterile Drug Products Produced by Aseptic Processing (Draft)  HTM  PDF  Word