Food and Drug Administration
Advisory Committee for Pharmaceutical Science
May 7-8, 2002
Briefing Information
May 8, 2002
Analytical Technologies (PAT): Closing Remarks, Ajaz Hussain, PhD Deputy Director, OPS pdf ppt
Chemometric Working Group ppt htm
Product & Process Working Group ppt htm
Process Analytical Technologies (PATs), Applications & Benefits Working Group ppt htm
Process & Analytical Validation Working Group ppt htm
Guidance for Industry: ANDAs: Blend Uniformity Analysis, Draft Guidance, August 3, 1999 pdf
Letter dated March 28, 2002 from PQRI to Janet Woodcock, MD, Dir, CDER, FDA pdf
Decision Tree #4 Investigating the Need to Set Acceptance Criteria for Polymorphism in Drug Substances and Drug Products pdf
International Conference on Harmonization Guidance on Q6A Specifications (December 29, 2000, 65FR83041) pdf
Particle Size and Polymorph of Drug Substance Summary Slides ppt htm
Issues of Polymorphism and Abbreviated New Drug Applications htm doc pdf
April 15, 2002 Response to Arnold & Porter on Citizen Petitions (Docket No. 00P-1550/CP1 & PSA1; Dockets No. 01P-0428/CP1 & PSA1) pdf
Agency Position on Polymorphism and Abbreviated new Drug Applications pdf
Approved Drug Products pdf
USPC, Inc. Chloramphenicol Palmitate Oral Suspension pdf
USPC, Inc. Idarubicin Hydrochloride pdf
Guidance For Industry: Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances pdf